FDA 510(k) Application Details - K972042

Device Classification Name Spirometer, Therapeutic (Incentive)

  More FDA Info for this Device
510(K) Number K972042
Device Name Spirometer, Therapeutic (Incentive)
Applicant PARI HOLDING CO.
13800 HULL ST. RD.
MIDLOTHIAN, VA 23112 US
Other 510(k) Applications for this Company
Contact MIGUEL A ARRIZON
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 06/02/1997
Decision Date 08/05/1997
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact