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FDA 510(k)

TOTAL WORK INTEGRATOR, MODEL #940-110

K-Number: K922603 · 1992-06-19

ApplicantBiodan Medical Systems, Ltd.
Decision Date1992-06-19
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TOTAL WORK INTEGRATOR, MODEL #940-110 is the device name listed in this FDA 510(k) record. The listed applicant is Biodan Medical Systems, Ltd.. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K922603. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL WORK INTEGRATOR, MODEL #940-110?

TOTAL WORK INTEGRATOR, MODEL #940-110 is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Biodan Medical Systems, Ltd.. The 510(k) number is K922603.

When did TOTAL WORK INTEGRATOR, MODEL #940-110 receive FDA 510(k) clearance?

TOTAL WORK INTEGRATOR, MODEL #940-110 received FDA 510(k) clearance on 1992-06-19, under 510(k) number K922603.

Who is the listed applicant for TOTAL WORK INTEGRATOR, MODEL #940-110?

The FDA 510(k) record lists Biodan Medical Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL WORK INTEGRATOR, MODEL #940-110?

The FDA product code for TOTAL WORK INTEGRATOR, MODEL #940-110 is ISD.

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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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