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FDA 510(k)

DANTEC DUET

K-Number: K960503 · 1996-09-16

ApplicantDantec Medical, Inc.
Decision Date1996-09-16
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DANTEC DUET is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1996-09-16 under 510(k) number K960503. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANTEC DUET?

DANTEC DUET is a medical device that received FDA 510(k) clearance on 1996-09-16. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K960503.

When did DANTEC DUET receive FDA 510(k) clearance?

DANTEC DUET received FDA 510(k) clearance on 1996-09-16, under 510(k) number K960503.

Who is the listed applicant for DANTEC DUET?

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

What is the FDA product code for DANTEC DUET?

The FDA product code for DANTEC DUET is FEN.

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Other records listing Dantec Medical, 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.

K950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP LK932059NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE

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Related Devices (Code: FEN)

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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