510(k) K982789

MEDICAL AIR COMPRESSOR, MODEL # 8413419 by Drager, Inc. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1998
Date Received
August 10, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type