WatchPAT200U (WP200U)— 510(k) K203839
Substantially EquivalentItamar Medical , Ltd.
FDA 510(k) clearance K203839 for WatchPAT200U (WP200U), Substantially Equivalent on 2022-03-21. Applicant: Itamar Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Itamar Medical , Ltd.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea, IL
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