Cleared Traditional

K971865 - ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
(FDA 510(k) Clearance)

K971865 · Alexander Mfg. Co. · General Hospital

Jul 1997

Decision

44d

Days

Class 2

Risk

K971865 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P, a Controller, Infusion, Intravascular, Electronic (Class II — Special Controls, product code LDR), submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on July 3, 1997, 44 days after receiving the submission on May 20, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K971865 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1997
Decision Date	July 03, 1997
Days to Decision	44 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement