510(k) K972086

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 by Alexander Mfg. Co. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1997
Date Received
June 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type