FDA 510(k) Application Details - K024322

Device Classification Name Ventilatory Effort Recorder

  More FDA Info for this Device
510(K) Number K024322
Device Name Ventilatory Effort Recorder
Applicant MEDCARE FLAGA
46 LOCH HAVEN LN.
BATTLE CREEK, MI 49015 US
Other 510(k) Applications for this Company
Contact KUMAR KULKARNI
Other 510(k) Applications for this Contact
Regulation Number 868.2375

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

  More FDA Info for this Product Code
Date Received 12/26/2002
Decision Date 10/27/2003
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