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K Number
K971604
Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1997-07-28

(88 days)

Product Code
DSH
Regulation Number
870.2800
Type
Traditional
Panel
CV
Reference & Predicate Devices
K884911,K850011,K760676,K790757
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Device Description

Replacement Battery Part Number LP5-FP

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a replacement battery (LP5-FP). It does not contain information about acceptance criteria or a study demonstrating device performance.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study that proves the device meets those criteria.

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).