FDA 510(k) Application Details - K072757

Device Classification Name Chamber, Hyperbaric

  More FDA Info for this Device
510(K) Number K072757
Device Name Chamber, Hyperbaric
Applicant SUMMIT TO SEA
1744 AVOCET LANE
MOUND, MN 55364 US
Other 510(k) Applications for this Company
Contact BRUCE MCKEEMAN
Other 510(k) Applications for this Contact
Regulation Number 868.5470

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

  More FDA Info for this Product Code
Date Received 09/27/2007
Decision Date 02/08/2008
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