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FDA 510(k)

BIO MEDICUS BIO CONSOLE 540

K-Number: K854133 · 1986-01-08

ApplicantBio Medicus, Inc.
Decision Date1986-01-08
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO MEDICUS BIO CONSOLE 540 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 1986-01-08 under 510(k) number K854133. 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 540?

BIO MEDICUS BIO CONSOLE 540 is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K854133.

When did BIO MEDICUS BIO CONSOLE 540 receive FDA 510(k) clearance?

BIO MEDICUS BIO CONSOLE 540 received FDA 510(k) clearance on 1986-01-08, under 510(k) number K854133.

Who is the listed applicant for BIO MEDICUS BIO CONSOLE 540?

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 MEDICUS BIO CONSOLE 540?

The FDA product code for BIO MEDICUS BIO CONSOLE 540 is DWA.

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Other records listing Bio Medicus, Inc. as applicant

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.

K920761URINE CULTUR STABILIZATION TRANSPORT TUBEK903410BIO-MEDICUS CANNULA INTRODUCERK901253(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B CK894980BIO-CAL 370 HEATER/COOLERK884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET

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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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