Company ยท US
Instrumentarium Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2002. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 4 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| IZH | System, X-Ray, Mammographic | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 1 |
| DPS | Electrocardiograph | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| FFT | Electrode, Ph, Stomach | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2002 | K022630 | MODIFICATION TO FOCUS Instrumentarium Corp. | EHD |
| Jul 13, 2000 | K001729 | FOCUS Instrumentarium Corp. | EHD |
| Jun 22, 2000 | K001439 | ORTHOCEPH OC100 D Instrumentarium Corp. | MUH |
| Sep 28, 1999 | K992385 | ORTHOPANTOMOGRAPH OP100D Instrumentarium Corp. | MUH |
| Jul 17, 1998 | K981641 | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ Instrumentarium Corp. | IZH |
| Apr 4, 1997 | K962638 | TONOCAP, TC-200 AND ACCESSORY CATHETERS Instrumentarium Corp. | CCK |
| Apr 30, 1996 | K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL Instrumentarium Corp. | JJS |
| Jan 30, 1996 | K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR Instrumentarium Corp. | FFT |
| Jan 31, 1995 | K934478 | ALPHA STEREO Instrumentarium Corp., FI | IZH |
| Jul 22, 1993 | K923433 | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE Instrumentarium Corp., FI | CBQ |
| Apr 27, 1993 | K930338 | ORTHOCEPH OC100 Instrumentarium Corp., FI | EHD |
| Nov 5, 1991 | K912893 | ORTHOPANTOMOGRAPH 100 Instrumentarium Corp., FI | EHD |
| May 23, 1991 | K904355 | CARDIOCAP II TM CH-RESP MONITORS Instrumentarium Corp., FI | DPS |
| Nov 10, 1988 | K883621 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM Instrumentarium Corp. | LNH |
| Oct 19, 1988 | K883649 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H Instrumentarium Corp. | LNH |
| Sep 16, 1988 | K883650 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110 Instrumentarium Corp. | LNH |
| Sep 14, 1988 | K883622 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM Instrumentarium Corp. | LNH |
| Jun 2, 1986 | K853953 | CARDIOCAP MONITOR Instrumentarium Corp. | DRT |
| Aug 16, 1985 | K853396 | MULTICAP MULTIGAS CAPNOMETER PB252 Instrumentarium Corp., FI | CCK |
| Dec 16, 1983 | K833739 | CD-102 CARBON DIOXIDE ANALYZER/RECOR Instrumentarium Corp. | CCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||