UltraviewSL 91482
by Spacelabs Healthcare (Washington), Inc
UltraviewSL 91482 is a patient monitoring system module (FDA Class II) made by Spacelabs Healthcare (Washington), Inc, cleared under FDA 510(k) K060900 on 23 Jun 2006 and listed in FDA GUDID since 13 May 2024 (UDI-DI 10841522108754), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10841522108754 | Date13 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060900 | Date23 Jun 2006 | StatusActive |
Official records
- AccessGUDID record 10841522108754
- FDA 510(k) database K060900
Across registries
- FDA 510(k) K060900 decided 23 Jun 2006 Active
- FDA GUDID UDI-DI 10841522108754 listed 13 May 2024 Listed
Timeline
- Cleared FDA 510(k) K060900
- Listed FDA GUDID 10841522108754
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- UltraviewSL
- Generic name
- Patient monitoring system module, electroencephalographic
- Model / Ref / Catalog
- 91482
- Primary DI / UDI-DI
- 10841522108754
- 510(k) Number
- FDA product code
- OLT, ORT, OMC, OLW
- GMDN term
- Patient monitoring system module, electroencephalographic
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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