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TYPE 9050/NEO

by S & W Medico Teknik

510(k) K912183

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 NumberK912183 Date23 Jun 1992ClearedStatusActive

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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
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.

TYPE 9050/NEO is a Class II ECG machine manufactured by S & W Medico Teknik. It is designed for cardiovascular applications and provides electrocardiogram monitoring capabilities.

The device is supplied by S & W Medico Teknik and received FDA 510(k) clearance on June 23, 1992, under K-number K912183 with product code DPS. It is cleared for use in cardiovascular settings and is regulated as a Class II medical device.

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