Company ยท US
Biosound, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1997. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 13 |
| DXK | Echocardiograph | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 |
| DPS | Electrocardiograph | 3 |
| GWQ | Full-Montage Standard Electroencephalograph | 3 |
| JOP | Transducer, Ultrasonic | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| IKN | Electromyograph, Diagnostic | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 1997 | K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER Biosound, Inc. | ITX |
| Mar 31, 1997 | K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER Biosound, Inc. | LMB |
| Mar 28, 1997 | K963262 | ARTOSCAN M Biosound, Inc. | LNH |
| Feb 26, 1997 | K963662 | GALILEO EVOKED POTENTIALRE Biosound, Inc. | GWF |
| Apr 17, 1996 | K953716 | INTRACAVITY TRANSDUCERS Biosound, Inc. | ITX |
| Apr 8, 1996 | K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A Biosound, Inc. | IYO |
| Mar 1, 1996 | K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER Biosound, Inc. | ITX |
| Mar 1, 1996 | K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER Biosound, Inc. | ITX |
| Feb 12, 1996 | K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES Biosound, Inc. | ITX |
| Feb 2, 1996 | K953579 | TEE PROBE Biosound, Inc. | ITX |
| Oct 24, 1995 | K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES Biosound, Inc. | ITX |
| Sep 18, 1995 | K941935 | LP-12 LAPAROSCOPIC PROBE Biosound, Inc. | ITX |
| Jun 2, 1995 | K944287 | 7050 ULTRASOUND IMAGING SYSTEM Biosound, Inc. | ITX |
| May 24, 1995 | K944485 | 4000 AU ULTRASOUND IMAGING SYSTEM Biosound, Inc. | IYO |
| Feb 3, 1994 | K934050 | TOPOGRAPHIC BRAIN MAPPING OPTION Biosound, Inc. | OLT |
| Oct 7, 1993 | K931022 | ARTOSCAN Biosound, Inc. | LNH |
| Apr 27, 1993 | K922703 | THE ACTA FORMULA Biosound, Inc. | DPS |
| Mar 10, 1993 | K923894 | YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH Biosound, Inc. | GWQ |
| Mar 2, 1993 | K922488 | PHASIS ELECTROMYOGRAPH Biosound, Inc. | IKN |
| Feb 4, 1993 | K923860 | THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR Biosound, Inc. | GWQ |
| Jan 26, 1993 | K923950 | THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH Biosound, Inc. | GWQ |
| Nov 4, 1992 | K922291 | PERSONAL 120/210 LAPTOP STRESS OPTION Biosound, Inc. | DPS |
| Jul 2, 1992 | K915860 | LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE Biosound, Inc. | ITX |
| May 15, 1992 | K913209 | ACCESSORY TO GENESIS III (GCFM) Biosound, Inc. | DXK |
| Apr 2, 1992 | K914006 | BIPLANE TRANSRECTAL PROBE Biosound, Inc. | ITX |
| Mar 17, 1992 | K920364 | ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS Biosound, Inc. | DPS |
| Dec 5, 1991 | K912088 | BIOPSY ACCESSORIES FOR ULTRASOUND PROBES Biosound, Inc. | ITX |
| Mar 6, 1990 | K895645 | BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM Biosound, Inc. | IYO |
| Jan 29, 1990 | K894370 | GENESIS III, (MOD. 7003/7004) Biosound, Inc. | DXK |
| Sep 12, 1989 | K894163 | PHASE 2 TRANSCRANIAL PROBE Biosound, Inc. | IYN |
| Aug 24, 1988 | K883238 | GENESIS II TRANSCRANIAL PROBE Biosound, Inc. | IYO |
| Aug 12, 1988 | K881723 | GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER Biosound, Inc. | JOP |
| May 20, 1988 | K871442 | BIOSOUND MMI ULTRASOUND Biosound, Inc. | JOP |
| Feb 18, 1988 | K873032 | GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN Biosound, Inc. | DXK |
| Dec 30, 1987 | K870899 | EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX Biosound, Inc. | ITX |
| Nov 6, 1987 | K871697 | GENESIS II Biosound, Inc. | DXK |
| Feb 2, 1987 | K862859 | EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND Biosound, Inc. | DXK |
| Nov 10, 1986 | K862841 | HIGH VELOCITY CW DOPPLER SYSTEM Biosound, Inc. | DPW |
| Apr 4, 1983 | K837063 | BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM Biosound, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||