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FDA 510(k)

BIOVISION CARDIAC STROBE

K-Number: K811341 · 1981-07-16

ApplicantCardiac Imaging
Decision Date1981-07-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOVISION CARDIAC STROBE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Imaging. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811341. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVISION CARDIAC STROBE?

BIOVISION CARDIAC STROBE is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Cardiac Imaging. The 510(k) number is K811341.

When did BIOVISION CARDIAC STROBE receive FDA 510(k) clearance?

BIOVISION CARDIAC STROBE received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811341.

Who is the listed applicant for BIOVISION CARDIAC STROBE?

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

What is the FDA product code for BIOVISION CARDIAC STROBE?

The FDA product code for BIOVISION CARDIAC STROBE is DPS.

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Related Devices (Code: DPS)

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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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