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FDA 510(k)

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E

K-Number: K924206 · 1993-05-07

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1993-05-07
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E 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 1993-05-07 under 510(k) number K924206. 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 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E?

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E is a medical device that received FDA 510(k) clearance on 1993-05-07. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K924206.

When did MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E receive FDA 510(k) clearance?

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E received FDA 510(k) clearance on 1993-05-07, under 510(k) number K924206.

Who is the listed applicant for MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E?

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 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E?

The FDA product code for MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E is DWA.

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Other records listing Medtronic Bio-Medicus, Inc. as applicant

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K973237CSS-CARDIOPLEGIA SAFETY SYSTEMK973011BPX80 BIO-PUMP (BPX80)K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMK941922MEDSAT OXYGEN SATURATION SYSTEMK936091MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLERK941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

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Related Devices (Code: DWA)

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.

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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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