Watch Pat 100S
510(k) K042916
Watch Pat 100S is a Class II device made by Itamar Medical Ltd, cleared under FDA 510(k) K042916 on 29 Dec 2004, active as of 13 Nov 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 | NumberK042916 | Date29 Dec 2004 | StatusActive |
Official records
- FDA 510(k) database K042916
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNR
- FDA applicant
- Itamar Medical
- Device class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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