FDA 510(k) Application Details - K222525

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K222525
Device Name	Spirometer, Diagnostic
Applicant	Roundworks Technologies Private Limited Office No. B 302, Building No. B, 3rd floor, GO Square, Survey No.249/250, Above Surya Electronic Wakad, Pune 411047 IN Other 510(k) Applications for this Company
Contact	Prashant Patel Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2022
Decision Date	08/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review