FDA 510(k) Application Details - K021689

Device Classification Name Chamber, Hyperbaric

  More FDA Info for this Device
510(K) Number K021689
Device Name Chamber, Hyperbaric
Applicant PAN-AMERICA HYPERBARICS, INC.
18111 COPPER RIDGE DR.
SAN ANTONIO, TX 78259-3612 US
Other 510(k) Applications for this Company
Contact W. T WORKMAN
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 05/23/2002
Decision Date 10/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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