FDA 510(k) Application Details - K970507

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K970507
Device Name	Meter, Peak Flow, Spirometry
Applicant	INTL. MEDICAL, INC. 14470 BURNSVILLE PKWY. BURNSVILLE, MN 55306 US Other 510(k) Applications for this Company
Contact	WARREN V BIGELOW Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/1997
Decision Date	06/13/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review