SleepCheckRx— 510(k) K213360
Substantially EquivalentResapp Health
FDA 510(k) clearance K213360 for SleepCheckRx, Substantially Equivalent on 2022-07-05. Applicant: Resapp Health. Device class: 2.
Clearance details
- Applicant
- Resapp Health
- 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
- Brisbane, AU
Recent devices under product code MNR
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