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FDA 510(k)

35MM ANGIOGRAM VIEWER ANALYZER

K-Number: K821491 · 1982-07-08

ApplicantBirtcher Corp.
Decision Date1982-07-08
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

35MM ANGIOGRAM VIEWER ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1982-07-08 under 510(k) number K821491. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 35MM ANGIOGRAM VIEWER ANALYZER?

35MM ANGIOGRAM VIEWER ANALYZER is a medical device that received FDA 510(k) clearance on 1982-07-08. The listed applicant is Birtcher Corp.. The 510(k) number is K821491.

When did 35MM ANGIOGRAM VIEWER ANALYZER receive FDA 510(k) clearance?

35MM ANGIOGRAM VIEWER ANALYZER received FDA 510(k) clearance on 1982-07-08, under 510(k) number K821491.

Who is the listed applicant for 35MM ANGIOGRAM VIEWER ANALYZER?

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

What is the FDA product code for 35MM ANGIOGRAM VIEWER ANALYZER?

The FDA product code for 35MM ANGIOGRAM VIEWER ANALYZER is DXJ.

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Other records listing Birtcher Corp. as applicant

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Related Devices (Code: DXJ)

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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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