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K Number
K972086
Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1997-08-12

(69 days)

Product Code
BZK
Regulation Number
868.1850
Type
Traditional
Panel
AN
Reference & Predicate Devices
K862687
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Replacement battery for OHMEDA (Ohio Medical Products) 690-1000-311 Volume Monitor 5400, 5410, 5420, 6800, 510(k) Number K862687. 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 MS311

AI/ML Overview

I am sorry, but after reviewing the provided documents, I could not find information about specific acceptance criteria for a device, nor details of a study proving a device meets such criteria. The documents are a letter from the FDA regarding a 510(k) clearance for a replacement battery (K972086) and its indications for use. They do not contain technical specifications, performance metrics, or study designs and results.

§ 868.1850 Monitoring spirometer.

(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).