HyperView 103-A001
HyperView 103-A001 is a Class II device made by Hypermed Imaging, Inc., cleared under FDA 510(k) K161237 on 16 Dec 2016 and listed in FDA GUDID since 23 Nov 2017 (UDI-DI 00869661000220), active as of 22 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 | Number00869661000220 | Date23 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161237 | Date16 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 00869661000220
- FDA 510(k) database K161237
Across registries
- FDA 510(k) K161237 decided 16 Dec 2016 Active
- FDA GUDID UDI-DI 00869661000220 listed 23 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K161237
- Listed FDA GUDID 00869661000220
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HyperView
- Generic name
- Patient monitoring system module, pulse oximetry
- Model / reference
- 103-A001
- Primary DI / UDI-DI
- 00869661000220
- 510(k) Number
- FDA product code
- MUD
- GMDN term
- Patient monitoring system module, pulse oximetry
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
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