Regional Oximeter
510(k) K102715
Regional Oximeter is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K102715 on 17 Dec 2010, 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 | FDA 510(k)SESE | NumberK102715 | Date17 Dec 2010 | StatusActive |
Official records
- FDA 510(k) database K102715
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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