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Airways (Guedel, Berman & Nasopharyngeal Types)

by Eastmed Enterprises, Inc.

510(k) K890342

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 NumberK890342 Date27 Apr 1989ClearedStatusActive

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  • Withdrawn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
BTO
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 tube, tracheostomy (with or without connector), classified under product code BTO and regulation number 868.5800. It is substantially equivalent to a legally marketed device and falls under the medical specialty of anesthesiology.

It received FDA 510(k) clearance (K890342) on April 27, 1989, following a traditional review process. The device is manufactured by Eastmed Enterprises, Inc. in Marlton, NJ, and is intended for use in anesthesiology-related airway management.

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