RespiraSense— 510(k) K220111

Substantially Equivalent

Pmd Solutions

FDA 510(k) clearance K220111 for RespiraSense, Substantially Equivalent on 2022-10-07. Applicant: Pmd Solutions.

Clearance details

Applicant: Pmd Solutions
Product code: Code BZQ
Advisory panel: Anesthesiology
Date received: 2022-01-13
Decision date: 2022-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

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