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MOM 2

by Neotronics, Inc.

510(k) K801607

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 NumberK801607 Date7 Aug 1980ClearedStatusActive

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  • Withdrawn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
CCL
Device Class
Class II
Regulation
21 CFR Part 868.1720
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 MOM 2 is a gas analyzer, oxygen, gaseous-phase device used for medical applications. It is classified under product code CCL and is intended for use in anesthesiology settings.

The device is authorized under FDA 510(k) clearance K801607 with a decision date of August 7, 1980. It is manufactured by Neotronics, Inc. and is not specified as single-use or reusable in the provided data. The device is stored at the manufacturer's facility located in McHenry, IL.

Other devices from Neotronics, Inc.

  • Era 2000A

    Class II