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FDA 510(k)

ELECTROSURGERY ANALYZER RF302

K-Number: K893659 · 1989-07-14

Decision Date1989-07-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGERY ANALYZER RF302 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K893659. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSURGERY ANALYZER RF302?

ELECTROSURGERY ANALYZER RF302 is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K893659.

When did ELECTROSURGERY ANALYZER RF302 receive FDA 510(k) clearance?

ELECTROSURGERY ANALYZER RF302 received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893659.

Who is the listed applicant for ELECTROSURGERY ANALYZER RF302?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROSURGERY ANALYZER RF302?

The FDA product code for ELECTROSURGERY ANALYZER RF302 is GEI.

Related Clinical Trials

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.

Other records listing Bio-Tek Instruments, 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.

View all 37 devices →

Related Devices (Code: GEI)

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.

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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