N20 TEST
FDA 510(k) clearance K853360 · decided 1985-09-03
Clearance details
- K-number
- K853360
- Device name
- N20 TEST
- Applicant
- Erich Jaeger, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-12
- Decision date
- 1985-09-03
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- CBR
- Device class
- 2
- Regulation number
- 868.1700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rockford, IL, 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 |
| SPACELABS MEDICAL MULTIGAS ANALYZER (K954962) | Spacelabs, Inc. | 1996-05-31 |
| OSCAR(TM) II CAPNOMETER & PULSE OXIMETER (K904843) | Dalton Instrument Corp. | 1991-04-09 |
Recalls involving this device
No recalls on record reference this clearance.