RespiraSense— 510(k) K220111
Substantially EquivalentPmd Solutions
FDA 510(k) clearance K220111 for RespiraSense, Substantially Equivalent on 2022-10-07. Applicant: Pmd Solutions. Device class: 2.
Clearance details
- Applicant
- Pmd Solutions
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cork, IE
Recent devices under product code BZQ
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