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FDA 510(k)

GENESIS

K-Number: K942553 · 1994-06-23

ApplicantBurton Medical Products Corp.
Decision Date1994-06-23
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENESIS is the device name listed in this FDA 510(k) record. The listed applicant is Burton Medical Products Corp.. It received FDA 510(k) clearance on 1994-06-23 under 510(k) number K942553. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS?

GENESIS is a medical device that received FDA 510(k) clearance on 1994-06-23. The listed applicant is Burton Medical Products Corp.. The 510(k) number is K942553.

When did GENESIS receive FDA 510(k) clearance?

GENESIS received FDA 510(k) clearance on 1994-06-23, under 510(k) number K942553.

Who is the listed applicant for GENESIS?

The FDA 510(k) record lists Burton Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENESIS?

The FDA product code for GENESIS is FTD.

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Other records listing Burton Medical Products Corp. 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.

K101537AIM 200, MAJOR SURGICAL LIGHTK042395OUTPATIENT III MINOR SURGERY LIGHTK000639VISIONARY 2000K963682GENIE' SINGLE CEILING AND DOUBLE CEILINGK961843GENIEK935102SATURN LIGHT

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Related Devices (Code: FTD)

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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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