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Namtai

by Nam Tai Electronics (Canada), Ltd. 2 variants

510(k) K935652

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 NumberK935652 Date29 Dec 1993ClearedStatusActive

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  • Withdrawn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
DXN
FDA applicant
Nam Tai Electronics (Canada) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1130
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.

Namtai is a medical device classified under the cardiovascular advisory committee. It is identified by the product code DXN and is subject to FDA 510k regulatory oversight.

This device was determined to be substantially equivalent through a traditional clearance process. It is supplied by Nam Tai Electronics (Canada), Ltd. and is documented under k-number K935652.

Other devices from Nam Tai Electronics (Canada), Ltd.