Datex Division Instrumentarium Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 55
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K953175 | AS/3 ESTPR MODULE | February 6, 1997 |
| K961247 | AS/3 LIGHT MONITOR | October 23, 1996 |
| K943458 | AS/3 AIRWAY MODULE | February 14, 1995 |
| K945234 | AS/3 MEMORY MODULE, M0MEM | January 27, 1995 |
| K933156 | DATEX AS/3 PATIENT MONITOR | December 30, 1994 |
| K933285 | DATEX AS/3 TM ANAESTHESIA MONITOR | November 14, 1994 |
| K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT | October 17, 1994 |
| K923172 | ANAESTHESIA RECORD KEEPER | August 9, 1994 |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | August 1, 1994 |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | July 27, 1994 |
| K933284 | AS/3 TM NETWORK | July 11, 1994 |
| K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | November 29, 1993 |
| K931422 | DELTATRAC(TM) II METABOLIC MONITOR | November 24, 1993 |
| K923276 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | July 21, 1993 |
| K922876 | AS/3 COP MODULE | July 21, 1993 |
| K911644 | NGM FRAME | March 4, 1992 |
| K911645 | NGM NIBP MODULE | March 4, 1992 |
| K911646 | NGM ESTP MODULE | February 21, 1992 |
| K911647 | NGM GAS MODULE | September 19, 1991 |
| K903237 | CARDIOCAP CMX-104 MONITOR | July 17, 1991 |