UltraviewSL Module: BISx
by Spacelabs Healthcare (Washington), Inc
UltraviewSL Module: BISx (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 10 Oct 2016 (UDI-DI 10841522100253), 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 | Number10841522100253 | Date10 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060900 | Date23 Jun 2006 | StatusActive |
Official records
- AccessGUDID record 10841522100253
- FDA 510(k) database K060900
Across registries
- FDA 510(k) K060900 decided 23 Jun 2006 Active
- FDA GUDID UDI-DI 10841522100253 listed 10 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K060900
- Listed FDA GUDID 10841522100253
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- Withdrawn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
- Module: BISx, 91482
- Primary DI / UDI-DI
- 10841522100253
- 510(k) Number
- FDA product code
- OMC, OLW, ORT, OLT
- 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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