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)

TABATABA COTESTER

K-Number: K080278 · 2008-11-28

ApplicantFim Medical
Decision Date2008-11-28
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TABATABA COTESTER is the device name listed in this FDA 510(k) record. The listed applicant is Fim Medical. It received FDA 510(k) clearance on 2008-11-28 under 510(k) number K080278. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TABATABA COTESTER?

TABATABA COTESTER is a medical device that received FDA 510(k) clearance on 2008-11-28. The listed applicant is Fim Medical. The 510(k) number is K080278.

When did TABATABA COTESTER receive FDA 510(k) clearance?

TABATABA COTESTER received FDA 510(k) clearance on 2008-11-28, under 510(k) number K080278.

Who is the listed applicant for TABATABA COTESTER?

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

What is the FDA product code for TABATABA COTESTER?

The FDA product code for TABATABA COTESTER is CCJ.

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.

Other records listing Fim Medical 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.

Related Devices (Code: CCJ)

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.

↑