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FDA 510(k)

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

K-Number: K924208 · 1993-07-08

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1993-07-08
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) 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 1993-07-08 under 510(k) number K924208. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)?

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K924208.

When did BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) receive FDA 510(k) clearance?

BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) received FDA 510(k) clearance on 1993-07-08, under 510(k) number K924208.

Who is the listed applicant for BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)?

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-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)?

The FDA product code for BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) is DPT.

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

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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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