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K Number
K971107
Device Name
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
Manufacturer
ALEXANDER MFG. CO.
Date Cleared
1997-06-05

(71 days)

Product Code
BTA
Regulation Number
878.4780
Type
Traditional
Panel
SU
Reference & Predicate Devices
K951281,K942018,K840110
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018).

This battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) 14 Number K840110.

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 STR5

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a replacement battery. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.