Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNIMEDICAL 400L

K-Number: K771990 · 1977-11-30

Decision Date1977-11-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNIMEDICAL 400L is the device name listed in this FDA 510(k) record. The listed applicant is Omnimedical Services, Inc.. It received FDA 510(k) clearance on 1977-11-30 under 510(k) number K771990. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIMEDICAL 400L?

OMNIMEDICAL 400L is a medical device that received FDA 510(k) clearance on 1977-11-30. The listed applicant is Omnimedical Services, Inc.. The 510(k) number is K771990.

When did OMNIMEDICAL 400L receive FDA 510(k) clearance?

OMNIMEDICAL 400L received FDA 510(k) clearance on 1977-11-30, under 510(k) number K771990.

Who is the listed applicant for OMNIMEDICAL 400L?

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

What is the FDA product code for OMNIMEDICAL 400L?

The FDA product code for OMNIMEDICAL 400L is JAK.

Related Clinical Trials

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.

Related Devices (Code: JAK)

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.

Official Source

View on FDA Database →

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

↑