FDA 510(k) Application Details - K202837

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K202837
Device Name	Spirometer, Diagnostic
Applicant	Monitored Therapeutics, Inc. 5995 Shier Rings Road, Ste A Dublin, OH 43016 US Other 510(k) Applications for this Company
Contact	Michael Taylor 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	09/25/2020
Decision Date	12/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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