SPEACELABS MULTIGAS MODULE
FDA 510(k) clearance K112173 · decided 2011-10-05
Clearance details
- K-number
- K112173
- Device name
- SPEACELABS MULTIGAS MODULE
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-07-28
- Decision date
- 2011-10-05
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- CBR
- Device class
- 2
- Regulation number
- 868.1700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| 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 |
| N20 TEST (K853360) | Erich Jaeger, Inc. | 1985-09-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Pro recall (Z-2077-2014) | Spacelabs Healthcare Inc | 2014-07-17 |