510(k) K971240

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 by Alexander Mfg. Co. — Product Code HEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1997
Date Received
April 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Heart Rate, Fetal, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type