FDA 510(k)

MOM 2

K-Number: K801607 · 1980-08-07

Decision Date1980-08-07

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MOM 2 is the device name listed in this FDA 510(k) record. The listed applicant is Neotronics, Inc.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801607. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOM 2?

MOM 2 is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Neotronics, Inc.. The 510(k) number is K801607.

When did MOM 2 receive FDA 510(k) clearance?

MOM 2 received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801607.

Who is the listed applicant for MOM 2?

The FDA 510(k) record lists Neotronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOM 2?

The FDA product code for MOM 2 is CCL.

Other records listing Neotronics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K911261ERA 2000A

Related Devices (Code: CCL)

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs K251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLC K221734Maxtec MaxO2 ME+pMaxtec, LLC K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.