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FDA 510(k)

BIOTRACE, MODEL 1730

K-Number: K002063 · 2000-08-10

ApplicantBryan Corp.
Decision Date2000-08-10
Product CodeMYU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOTRACE, MODEL 1730 is the device name listed in this FDA 510(k) record. The listed applicant is Bryan Corp.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K002063. The device is classified under product code MYU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACE, MODEL 1730?

BIOTRACE, MODEL 1730 is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Bryan Corp.. The 510(k) number is K002063.

When did BIOTRACE, MODEL 1730 receive FDA 510(k) clearance?

BIOTRACE, MODEL 1730 received FDA 510(k) clearance on 2000-08-10, under 510(k) number K002063.

Who is the listed applicant for BIOTRACE, MODEL 1730?

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

What is the FDA product code for BIOTRACE, MODEL 1730?

The FDA product code for BIOTRACE, MODEL 1730 is MYU.

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Other records listing Bryan 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.

K913242MICROPROCESSED CONTROLLED LAPAROFLATORK894380DUMON TRACHEOBRONCHIAL STENTK881249BAGGISH, HYSTEROSCOPEK854414DUMON/HARRELL

Related Devices (Code: MYU)

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.

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAParallax Medical, Inc.K032388BONE CEMENT RADIO-OPACIFIERCardinalhealthK024359VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1Vista Scientific, LLCK023445TRACERS BONE CEMENT OPACIFIERParallax Medical, Inc.K991893PARALLAX TRACER RADIOPAQUE PARTICLESParallax Medical, Inc.

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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