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FDA 510(k)

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

K-Number: K941921 · 1994-07-20

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1994-07-20
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Bio-Medicus, Inc.. It received FDA 510(k) clearance on 1994-07-20 under 510(k) number K941921. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550?

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K941921.

When did BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 receive FDA 510(k) clearance?

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 received FDA 510(k) clearance on 1994-07-20, under 510(k) number K941921.

Who is the listed applicant for BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550?

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

What is the FDA product code for BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550?

The FDA product code for BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 is DWA.

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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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