510(k) K841822

KEYMED SIGMOIDOSCOPE SUCTION UNIT by Keymed, Inc. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1984
Date Received
May 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type