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FDA 510(k)

BONART ART-E1 ELECTROSURGERY UNIT

K-Number: K020080 · 2002-02-19

ApplicantDiagnostic Data, Inc.
Decision Date2002-02-19
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONART ART-E1 ELECTROSURGERY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Data, Inc.. It received FDA 510(k) clearance on 2002-02-19 under 510(k) number K020080. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONART ART-E1 ELECTROSURGERY UNIT?

BONART ART-E1 ELECTROSURGERY UNIT is a medical device that received FDA 510(k) clearance on 2002-02-19. The listed applicant is Diagnostic Data, Inc.. The 510(k) number is K020080.

When did BONART ART-E1 ELECTROSURGERY UNIT receive FDA 510(k) clearance?

BONART ART-E1 ELECTROSURGERY UNIT received FDA 510(k) clearance on 2002-02-19, under 510(k) number K020080.

Who is the listed applicant for BONART ART-E1 ELECTROSURGERY UNIT?

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

What is the FDA product code for BONART ART-E1 ELECTROSURGERY UNIT?

The FDA product code for BONART ART-E1 ELECTROSURGERY UNIT is EKZ.

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Related Devices (Code: EKZ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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