WATCH-PAT MODEL 100S-2— 510(k) K080427
Substantially EquivalentItamar Medical
FDA 510(k) clearance K080427 for WATCH-PAT MODEL 100S-2, Substantially Equivalent on 2008-05-23. Applicant: Itamar Medical. Device class: 2.
Clearance details
- Applicant
- Itamar Medical
- 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
- Washington, DC, US
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