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FDA 510(k)

BIO-PROBE SYSTEM-BLOOD FLOW PROBE

K-Number: K830858 · 1983-06-08

ApplicantBio Medicus, Inc.
Decision Date1983-06-08
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-PROBE SYSTEM-BLOOD FLOW PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medicus, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830858. 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 SYSTEM-BLOOD FLOW PROBE?

BIO-PROBE SYSTEM-BLOOD FLOW PROBE is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K830858.

When did BIO-PROBE SYSTEM-BLOOD FLOW PROBE receive FDA 510(k) clearance?

BIO-PROBE SYSTEM-BLOOD FLOW PROBE received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830858.

Who is the listed applicant for BIO-PROBE SYSTEM-BLOOD FLOW PROBE?

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

What is the FDA product code for BIO-PROBE SYSTEM-BLOOD FLOW PROBE?

The FDA product code for BIO-PROBE SYSTEM-BLOOD FLOW PROBE is DPT.

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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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