Company ยท US
Bio-Logic Systems Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2012. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EWO | Audiometer | 9 |
| GWJ | Stimulator, Auditory, Evoked Response | 7 |
| GWQ | Full-Montage Standard Electroencephalograph | 7 |
| GWE | Stimulator, Photic, Evoked Response | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 3 |
| OLV | Standard Polysomnograph With Electroencephalograph | 3 |
| GWK | Conditioner, Signal, Physiological | 2 |
| GWN | Nystagmograph | 2 |
| GXY | Electrode, Cutaneous | 2 |
| IKN | Electromyograph, Diagnostic | 2 |
| MNR | Ventilatory Effort Recorder | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 |
| HCC | Device, Biofeedback | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2012 | K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM Bio-Logic Systems Corp. | EWO |
| Jul 26, 2012 | K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM Bio-Logic Systems Corp. | EWO |
| Feb 5, 2008 | K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM Bio-Logic Systems Corp. | GWJ |
| Sep 15, 2006 | K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS Bio-Logic Systems Corp. | EWO |
| Aug 26, 2005 | K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER Bio-Logic Systems Corp. | OLV |
| Jul 16, 2003 | K031352 | BIO-LOGIC INSERT EARPHONES Bio-Logic Systems Corp. | EWO |
| May 9, 2003 | K030907 | STACKED ABR FOR NAVIGATOR PRO Bio-Logic Systems Corp. | GWJ |
| Apr 28, 2003 | K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM Bio-Logic Systems Corp. | GWJ |
| Jul 1, 2002 | K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM Bio-Logic Systems Corp. | GWJ |
| Jun 27, 2002 | K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS Bio-Logic Systems Corp. | EWO |
| May 15, 2002 | K021215 | BIO-LOGIC ABAER CUB Bio-Logic Systems Corp. | GWJ |
| Oct 15, 2001 | K012384 | EAR MUFFINS Bio-Logic Systems Corp. | HCC |
| Dec 21, 2000 | K003681 | BIO-LOGIC SLEEPSCAN NETLINK Bio-Logic Systems Corp. | OLV |
| Sep 14, 2000 | K002570 | BIO-LOGIC CEEGRAPH NETLINK Bio-Logic Systems Corp. | GWQ |
| Dec 27, 1999 | K994149 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. Bio-Logic Systems Corp. | GWJ |
| Sep 14, 1999 | K992807 | BIO-LOGIC EVOKED POTENTIAL FOR ABAER I Bio-Logic Systems Corp. | GWJ |
| Nov 25, 1998 | K983913 | MODIFICATION TO BIO-LOGIC SLEEPSCAN Bio-Logic Systems Corp. | OLV |
| Mar 5, 1998 | K973883 | BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM Bio-Logic Systems Corp. | GWQ |
| Jan 22, 1998 | K974076 | SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE Bio-Logic Systems Corp. | EWO |
| Oct 14, 1997 | K971501 | SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER Bio-Logic Systems Corp. | MNR |
| May 13, 1997 | K964132 | MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT Bio-Logic Systems Corp. | EWO |
| Aug 22, 1996 | K962103 | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER Bio-Logic Systems Corp. | MNR |
| May 29, 1996 | K961447 | SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT Bio-Logic Systems Corp. | EWO |
| Jan 25, 1996 | K954954 | CEEGRAPH TRAVELER AMBULATORY EEG RECORDER Bio-Logic Systems Corp. | GWQ |
| Jan 3, 1996 | K944314 | DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123 Bio-Logic Systems Corp. | GXY |
| Aug 22, 1995 | K951594 | BIO-LOGIC AUTOMATIC EVENT ANALYSIS Bio-Logic Systems Corp. | OMB |
| Feb 3, 1995 | K941928 | VARIOUS ELECTRODES Bio-Logic Systems Corp. | GWN |
| Feb 3, 1995 | K941799 | DISPOSABLE CUTANEOUS ELECTRODES Bio-Logic Systems Corp. | GXY |
| Dec 21, 1994 | K944735 | BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST Bio-Logic Systems Corp. | EWO |
| Mar 3, 1994 | K933233 | CEEGRAPH, MODIFICATION Bio-Logic Systems Corp. | GWQ |
| Jan 6, 1994 | K930790 | ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. Bio-Logic Systems Corp. | BZQ |
| Jul 2, 1993 | K930328 | NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT Bio-Logic Systems Corp. | IKN |
| Mar 20, 1990 | K893130 | EMG NAVIGATOR & EMG TRAVELER Bio-Logic Systems Corp. | IKN |
| Dec 22, 1989 | K895125 | CEEGRAPH Bio-Logic Systems Corp. | GWQ |
| Mar 25, 1988 | K874136 | PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL Bio-Logic Systems Corp. | GWE |
| Oct 6, 1987 | K872290 | BIO-LOGIC BANKER Bio-Logic Systems Corp. | GWK |
| Apr 16, 1987 | K870337 | AUDIOMETER Bio-Logic Systems Corp. | ETW |
| Nov 25, 1986 | K862690 | TRAVELER LT Bio-Logic Systems Corp. | GWF |
| Apr 22, 1986 | K854362 | MODIFIED BRAIN ATLAS III Bio-Logic Systems Corp. | GWE |
| Dec 12, 1985 | K852533 | L.E.D. GOGGLES, MODEL 580-LEDGOG Bio-Logic Systems Corp. | GWE |
| Jul 22, 1985 | K850180 | ELECTRONYSTAGMOGRAPH (ENG RECORDER) Bio-Logic Systems Corp. | GWN |
| Jun 7, 1985 | K844992 | BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM Bio-Logic Systems Corp. | GWF |
| Nov 29, 1984 | K842543 | EVOKED POTENTIAL SYS Bio-Logic Systems Corp. | GWF |
| May 13, 1983 | K831047 | BIOLOGIC SYSTEM BL 101 Bio-Logic Systems Corp. | GWE |
| Feb 5, 1981 | K803226 | EVOKED RESPONSE STIMULATORS Bio-Logic Systems Corp. | GWK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2007 | Bio-Logic Systems Corp Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model Terminated |
GWQ | K052066 |
| Apr 20, 2007 | Bio-Logic Systems Corp Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a bui Terminated |
GWQ | K052066 |