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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K222525
Device Name Alveoair Digital Spirometer
Applicant
Roundworks Technologies Private Limited
Office # B 302, Bldg. # B, 3rd Floor, Go Sq.,
Survey #249/250, Above Surya Electronic
Wakad, Pune,  IN 411047
Applicant Contact Prashant Patel
Correspondent
IZiel Healthcare
14, Hadapsar Industrial Estate, Hadapsar
Pune,  IN 411013
Correspondent Contact Ankur Naik
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/22/2022
Decision Date 08/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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