SPACELABS MEDICAL MULTIGAS ANALYZER
FDA 510(k) clearance K954962 · decided 1996-05-31
Clearance details
- K-number
- K954962
- Device name
- SPACELABS MEDICAL MULTIGAS ANALYZER
- Applicant
- Spacelabs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-30
- Decision date
- 1996-05-31
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- CBR
- Device class
- 2
- Regulation number
- 868.1700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Redmond, WA, 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 |
|---|---|---|
| SPEACELABS MULTIGAS MODULE (K112173) | Spacelabs Healthcare | 2011-10-05 |
| SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (K053599) | Spacelabs Medical, Inc. | 2006-04-19 |
| OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (K904843) | Dalton Instrument Corp. | 1991-04-09 |
| N20 TEST (K853360) | Erich Jaeger, Inc. | 1985-09-03 |
Recalls involving this device
No recalls on record reference this clearance.