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Alexander Manufacturing Co. Rechargeable Battery Part Number M850-P

by Alexander Mfg. Co.

510(k) K972787

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972787 Date17 Oct 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a rechargeable battery, identified as part number M850-P, manufactured by Alexander Manufacturing Co. It is classified as a cardiac monitor (including cardiotachometer and rate alarm) under FDA device class 2, based on the openFDA data associated with its authorization.

The device received traditional 510(k) clearance (K972787) on October 17, 1997, after being found substantially equivalent. It is authorized for use in the cardiovascular medical specialty and is associated with multiple facility establishment identifiers (FEIs) and registration numbers as listed in the specifications.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Alexander Mfg. Co. rechargeable battery M850-P used for?

    The Alexander Mfg. Co. rechargeable battery part number M850-P is used as a power source for cardiac monitors, including devices that provide cardiotachometer and rate alarm functions, based on its classification under FDA device class 2 for cardiovascular medical specialty equipment.

  • Is the Alexander Mfg. Co. M850-P battery rechargeable or single-use?

    The Alexander Mfg. Co. M850-P battery is designed as a rechargeable battery, as indicated in its product name and description, meaning it can be recharged and reused multiple times rather than being disposed of after a single use.

  • What regulatory pathway was used for the Alexander Mfg. Co. M850-P battery?

    The Alexander Mfg. Co. M850-P battery received traditional 510(k) clearance under number K972787 on October 17, 1997, after being determined substantially equivalent to a predicate device, which is the regulatory pathway used for its authorization.