FDA 510(k) Application Details - K190568

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K190568
Device Name	Spirometer, Diagnostic
Applicant	Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill, MA 01832 US Other 510(k) Applications for this Company
Contact	Deborah Cornish 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	03/06/2019
Decision Date	06/06/2019
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
Expedited Review