FDA 510(k) Application Details - K023097

Device Classification Name Meter, Peak Flow, Spirometry

  More FDA Info for this Device
510(K) Number K023097
Device Name Meter, Peak Flow, Spirometry
Applicant MONAGHAN MEDICAL CORP.
5 LATOUR AVE., SUITE 1600
P.O. BOX 2805
PLATTSBURGH, NY 12901 US
Other 510(k) Applications for this Company
Contact JAMES A COCHIE
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 09/18/2002
Decision Date 03/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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