510(k) K972789

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 by Alexander Mfg. Co. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1997
Date Received
July 25, 1997
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