FDA 510(k) Application Details - K001528

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K001528
Device Name	Spirometer, Diagnostic
Applicant	SPIROMETRICS MEDICAL EQUIPMENT CO. 49 PLAIN ST. N. ATTLEBORO, MA 02760-4153 US Other 510(k) Applications for this Company
Contact	JAMES R VEALE 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	05/17/2000
Decision Date	01/18/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review