SPIROPALM— 510(k) K093174
Substantially EquivalentCosmed Srl
FDA 510(k) clearance K093174 for SPIROPALM, Substantially Equivalent on 2010-02-26. Applicant: Cosmed Srl. Device class: 2.
Clearance details
- Applicant
- Cosmed Srl
- Product code
- Code BZG
- Device class
- Class 2
- Regulation
- 21 CFR 868.1840
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
Recent devices under product code BZG
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