FDA 510(k) Application Details - K090829

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K090829
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. MIDLOTHIAN, VA 23112 US Other 510(k) Applications for this Company
Contact	MICHAEL JUDGE Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2009
Decision Date	07/21/2009
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