510(k) K790644

SUBMAX by Chase Mfg. Co. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1979
Date Received
March 30, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type