AS/3 COMPACT AIRWAY MODULE M-CAIOV
FDA 510(k) clearance K960490 · decided 1996-05-03
Clearance details
- K-number
- K960490
- Device name
- AS/3 COMPACT AIRWAY MODULE M-CAIOV
- Applicant
- Datex Medical Instrumentation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-02-02
- Decision date
- 1996-05-03
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- CBS
- Device class
- 2
- Regulation number
- 868.1620
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tewksbury, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GAS MODULE II, MODEL 0998-00-0143 (K974903) | Datascope Corp. | 1998-03-13 |
| VITALMAX 4100 (K953795) | Pace Tech, Inc. | 1996-07-01 |
| RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (K951366) | Riken Keiki Co., Ltd. | 1995-08-02 |
| RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (K950101) | Marquette Electronics, Inc. | 1995-03-21 |
| AS/3 AIRWAY MODULE (K943458) | Datex Division Instrumentarium Corp. | 1995-02-14 |
| POET IQ WITH FIVE AGENT CAPABILITY (K942737) | Criticare Systems, Inc. | 1995-02-09 |
| 8100 ANESTHETIC AGENT MONITOR (K932389) | Biochem International, Inc. | 1993-12-03 |
| CAPNOMAC ULTIMA ANESTHESIA MONITOR (K905754) | Datex Division Instrumentarium Corp. | 1991-06-17 |
| NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (K896629) | Nellcor, Inc. | 1990-02-12 |
| HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A (K896216) | Hewlett-Packard Co. | 1990-01-16 |
| ANESTHETIC GAS MONITOR (K890446) | Bruel & Kjaer Instruments, Inc. | 1989-08-11 |
| SPECTRAMED RESPIRATORY GAS ANALYZER (K873194) | Draeger Medical, Inc. | 1987-10-30 |
Recalls involving this device
No recalls on record reference this clearance.