FDA 510(k) Application Details - K963380

Device Classification Name Calculator, Pulmonary Function Data

  More FDA Info for this Device
510(K) Number K963380
Device Name Calculator, Pulmonary Function Data
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD, CT 06492 US
Other 510(k) Applications for this Company
Contact ROBERT H SCHIFFMAN
Other 510(k) Applications for this Contact
Regulation Number 868.1880

  More FDA Info for this Regulation Number
Classification Product Code BZC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/27/1996
Decision Date 01/22/1997
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