Apnea Risk Evaluation System (ARES), Model 620— 510(k) K160499
Substantially EquivalentWatermark Medical
FDA 510(k) clearance K160499 for Apnea Risk Evaluation System (ARES), Model 620, Substantially Equivalent on 2017-04-24. Applicant: Watermark Medical. Device class: 2.
Clearance details
- Applicant
- Watermark 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
- West Palm Beach, FL, US
Recent devices under product code MNR
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