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FDA 510(k)

BRONCHEK-SHILEY CARDIAC JACKET & BSC J

K-Number: K811204 · 1981-05-21

ApplicantShiley, Inc.
Decision Date1981-05-21
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRONCHEK-SHILEY CARDIAC JACKET & BSC J is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811204. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRONCHEK-SHILEY CARDIAC JACKET & BSC J?

BRONCHEK-SHILEY CARDIAC JACKET & BSC J is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Shiley, Inc.. The 510(k) number is K811204.

When did BRONCHEK-SHILEY CARDIAC JACKET & BSC J receive FDA 510(k) clearance?

BRONCHEK-SHILEY CARDIAC JACKET & BSC J received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811204.

Who is the listed applicant for BRONCHEK-SHILEY CARDIAC JACKET & BSC J?

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

What is the FDA product code for BRONCHEK-SHILEY CARDIAC JACKET & BSC J?

The FDA product code for BRONCHEK-SHILEY CARDIAC JACKET & BSC J is DTR.

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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.

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