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Alexander Mfg. Rechargeable Battery (Model M3/T)

by Alexander Mfg. Co.

510(k) K970784

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970784 Date14 May 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Alexander Mfg. Rechargeable Battery (Model M3/T) is a computer, diagnostic, pre-programmed, single-function device designed for cardiovascular applications. This battery serves as a power source for medical devices in the cardiovascular field.

The device is supplied by Alexander Mfg. Co. and is authorized under FDA 510(k) clearance with product code DXG. It is classified as a Class II medical device and regulated under 870.1435. The device has model number M3/T and was cleared on May 14, 1997.

Other devices from Alexander Mfg. Co.

See all devices from Alexander Mfg. Co. →

Questions

AI-generated answers, 22 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. Rechargeable Battery (Model M3/T) used for?

    The Alexander Mfg. Rechargeable Battery (Model M3/T) is a computer, diagnostic, pre-programmed, single-function device designed specifically as a power source for medical devices in the cardiovascular field.

  • How is the Alexander Mfg. Rechargeable Battery supplied?

    The device is supplied by Alexander Mfg. Co. and is classified as a Class II medical device with product code DXG, regulated under 870.1435.

  • What is the regulatory status of the Alexander Mfg. Rechargeable Battery?

    The Alexander Mfg. Rechargeable Battery (Model M3/T) is authorized under FDA 510(k) clearance with decision code SESE, having been cleared on May 14, 1997.

  • Is the Alexander Mfg. Rechargeable Battery reusable or single-use?

    The device is described as a rechargeable battery, indicating it is designed for multiple uses rather than being a single-use disposable product.