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FDA 510(k)

DUET

K-Number: K934970 · 1993-12-10

ApplicantTrulife , Ltd.
Decision Date1993-12-10
Product CodeGBJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUET is the device name listed in this FDA 510(k) record. The listed applicant is Trulife , Ltd.. It received FDA 510(k) clearance on 1993-12-10 under 510(k) number K934970. The device is classified under product code GBJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUET?

DUET is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Trulife , Ltd.. The 510(k) number is K934970.

When did DUET receive FDA 510(k) clearance?

DUET received FDA 510(k) clearance on 1993-12-10, under 510(k) number K934970.

Who is the listed applicant for DUET?

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

What is the FDA product code for DUET?

The FDA product code for DUET is GBJ.

Related Devices (Code: GBJ)

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.

K810282OPERATING TABLE ACCESSORY CLAMPMinnesota Scientific, Inc.K790946GORDON IVS INTRAVENOUS STABILIZERWhitman Medical Corp.K790186PROTECTIVSTABILIZERJelco Laboratories

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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