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FDA 510(k)

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER

K-Number: K936091 · 1994-12-23

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1994-12-23
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER 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 1994-12-23 under 510(k) number K936091. 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 550M PUMP SPEED CONTROLLER?

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER is a medical device that received FDA 510(k) clearance on 1994-12-23. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K936091.

When did MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER receive FDA 510(k) clearance?

MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER received FDA 510(k) clearance on 1994-12-23, under 510(k) number K936091.

Who is the listed applicant for MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER?

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 550M PUMP SPEED CONTROLLER?

The FDA product code for MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER 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 SYSTEMK941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550K924208BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

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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.

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)

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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