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FDA 510(k)

RETREAT

K-Number: K801606 · 1980-07-28

ApplicantOmnitronics Research Corp.
Decision Date1980-07-28
Product Code
DecisionSubstantially Equivalent

Device Summary

RETREAT is the device name listed in this FDA 510(k) record. The listed applicant is Omnitronics Research Corp.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801606. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETREAT?

RETREAT is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Omnitronics Research Corp.. The 510(k) number is K801606.

When did RETREAT receive FDA 510(k) clearance?

RETREAT received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801606.

Who is the listed applicant for RETREAT?

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

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.

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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.

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