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Preamplifier Model 113

by Princeton Applied Research Corp.

510(k) K781289

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 NumberK781289 Date14 Sep 1978ClearedStatusActive

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  • Withdrawn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
GWL
Device Class
Class II
Regulation
21 CFR Part 882.1835
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Preamplifier Model 113 is a low‑noise physiological signal amplifier classified as a Class II medical device. It is designed to amplify bio‑electrical signals for neurological applications, providing high fidelity and minimal added noise.

The device received traditional FDA 510(k) clearance (K781289) on 14 September 1978 and is listed under product code GWL. It is manufactured by Princeton Applied Research Corp. in Mchenry, Illinois, United States, and is supplied as a reusable, non‑sterile instrument without specific MRI safety or single‑use labeling.

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