FDA 510(k) Application Details - K983274

Device Classification Name Spirometer, Monitoring (W/Wo Alarm)

  More FDA Info for this Device
510(K) Number K983274
Device Name Spirometer, Monitoring (W/Wo Alarm)
Applicant NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
Other 510(k) Applications for this Company
Contact DAVID A.C. GREEN
Other 510(k) Applications for this Contact
Regulation Number 868.1850

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

  More FDA Info for this Product Code
Date Received 09/17/1998
Decision Date 12/09/1998
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



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