Alveoair Digital Spirometer— 510(k) K222525

Substantially Equivalent

Roundworks Technologies Private Limited

FDA 510(k) clearance K222525 for Alveoair Digital Spirometer, Substantially Equivalent on 2023-08-28. Applicant: Roundworks Technologies Private Limited. Device class: 2.

Clearance details

Applicant
Roundworks Technologies Private Limited
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
Wakad, Pune, IN
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