FDA 510(k)

UNKNOWN

K-Number: K827454 · 1982-09-29

Decision Date1982-09-29

Product Code

DecisionSubstantially Equivalent

Device Summary

UNKNOWN is the device name listed in this FDA 510(k) record. The listed applicant is Ote Biomedica. It received FDA 510(k) clearance on 1982-09-29 under 510(k) number K827454. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNKNOWN?

UNKNOWN is a medical device that received FDA 510(k) clearance on 1982-09-29. The listed applicant is Ote Biomedica. The 510(k) number is K827454.

When did UNKNOWN receive FDA 510(k) clearance?

UNKNOWN received FDA 510(k) clearance on 1982-09-29, under 510(k) number K827454.

Who is the listed applicant for UNKNOWN?

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ote Biomedica as applicant

K827286MODEL 8000 SECTOR IMAGER SYSTEM K827287MODEL 8100 SECTOR IMAGER

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.