SOMNOLYZER 24X7— 510(k) K083620
Substantially EquivalentThe Siesta Group North America
FDA 510(k) clearance K083620 for SOMNOLYZER 24X7, Substantially Equivalent on 2009-03-06. Applicant: The Siesta Group North America. Device class: 2.
Clearance details
- Applicant
- The Siesta Group North America
- 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
- Dedham, MA, US
Recent devices under product code MNR
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