SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
FDA 510(k) clearance K053599 · decided 2006-04-19
Clearance details
- K-number
- K053599
- Device name
- SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
- Applicant
- Spacelabs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-23
- Decision date
- 2006-04-19
- Days to decision
- 117 days
- Clearance type
- Special
- Product code
- CBR
- Device class
- 2
- Regulation number
- 868.1700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Issaquah, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Spacelabs Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K954962) | Spacelabs, Inc. | 1996-05-31 |
| 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
| Record | Firm | Date |
|---|---|---|
| Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare recall (Z-2902-2011) | Spacelabs Healthcare, Llc | 2011-08-01 |
| Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaqua recall (Z-0660-2008) | Spacelabs Healthcare, Incorporated | 2008-01-31 |