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K Number
K971235
Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1997-06-05

(64 days)

Product Code
DQA
Regulation Number
870.2700
Type
Traditional
Panel
AN
Reference & Predicate Devices
K863784
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Replacement battery for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.

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 for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a replacement battery, and it primarily focuses on the regulatory approval and substantial equivalence determination for this specific device. It does not include any details about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).