Spacelabs Multigas Module
by Spacelabs Healthcare (Washington), Inc
Spacelabs Multigas Module (92518) is a Class II device made by Spacelabs Healthcare (Washington), Inc, cleared under FDA 510(k) K112173 on 5 Oct 2011 and listed in FDA GUDID since 30 Nov 2016 (UDI-DI 10841522113109), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10841522113109 | Date30 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112173 | Date5 Oct 2011 | StatusActive |
Official records
- AccessGUDID record 10841522113109
- FDA 510(k) database K112173
Across registries
- FDA 510(k) K112173 decided 5 Oct 2011 Active
- FDA GUDID UDI-DI 10841522113109 listed 30 Nov 2016 Listed
Recalls
-
- Terminated Z-2077-2014
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Timeline
- Cleared FDA 510(k) K112173
- Recall initiated FDA recalls Z-2077-2014
- Listed FDA GUDID 10841522113109
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spacelabs
- Generic name
- Patient monitoring system module, multiple-gas
- Model / Ref / Catalog
- Multigas Module, 92518
- Primary DI / UDI-DI
- 10841522113109
- 510(k) Number
- FDA product code
- CBR, CCK, CBQ, NHQ, NHP, CCL, NHO, CBS
- GMDN term
- Patient monitoring system module, multiple-gas
- Device class
- Class II
- Regulation number
- 868.1700, 868.1400, 868.1500, 868.1720, 868.1620
- GUDID distribution status
- In Commercial Distribution
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