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K Number
K972787
Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1997-10-17

(84 days)

Product Code
DRT
Regulation Number
870.2300
Type
Traditional
Panel
CV
Reference & Predicate Devices
K772056
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Replacement battery for Datascope 0146-00-0019 Models 870 & 871 Physiological Monitors, 510(k) Number K76080 & K772056.

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 M850-P

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a replacement battery, and it does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).