FDA 510(k)

MODEL 8100 SECTOR IMAGER

K-Number: K827287 · 1982-08-06

Decision Date1982-08-06

Product Code

DecisionSubstantially Equivalent

Device Summary

MODEL 8100 SECTOR IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Ote Biomedica. It received FDA 510(k) clearance on 1982-08-06 under 510(k) number K827287. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 8100 SECTOR IMAGER?

MODEL 8100 SECTOR IMAGER is a medical device that received FDA 510(k) clearance on 1982-08-06. The listed applicant is Ote Biomedica. The 510(k) number is K827287.

When did MODEL 8100 SECTOR IMAGER receive FDA 510(k) clearance?

MODEL 8100 SECTOR IMAGER received FDA 510(k) clearance on 1982-08-06, under 510(k) number K827287.

Who is the listed applicant for MODEL 8100 SECTOR IMAGER?

The FDA 510(k) record lists Ote Biomedica 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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Other records listing Ote Biomedica as applicant

K827454UNKNOWN K827286MODEL 8000 SECTOR IMAGER SYSTEM

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.