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FDA 510(k)

TRACE MODEL #'S 840, 841, 842, 845

K-Number: K925145 · 1993-05-19

ApplicantTrace Medical Equipment, Inc.
Decision Date1993-05-19
Product CodeFYH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRACE MODEL #'S 840, 841, 842, 845 is the device name listed in this FDA 510(k) record. The listed applicant is Trace Medical Equipment, Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K925145. The device is classified under product code FYH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACE MODEL #'S 840, 841, 842, 845?

TRACE MODEL #'S 840, 841, 842, 845 is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Trace Medical Equipment, Inc.. The 510(k) number is K925145.

When did TRACE MODEL #'S 840, 841, 842, 845 receive FDA 510(k) clearance?

TRACE MODEL #'S 840, 841, 842, 845 received FDA 510(k) clearance on 1993-05-19, under 510(k) number K925145.

Who is the listed applicant for TRACE MODEL #'S 840, 841, 842, 845?

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

What is the FDA product code for TRACE MODEL #'S 840, 841, 842, 845?

The FDA product code for TRACE MODEL #'S 840, 841, 842, 845 is FYH.

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.

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Other records listing Trace Medical Equipment, 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.

K925502TRACE MODEL# 840, 841,842 & 845 ARM BOARD

Related Devices (Code: FYH)

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.

K924984SPECIALIST(R) WALKERJohnson & Johnson Orthopaedics, Inc.K895092KUT-SHIELDKut-Guard, Inc.K852558SPLINTS(ALL TYPE)The Huxley Instrument Corp.K843400HYDRO-SPLINT A SPONGE-COMPRESS DRESSCompression Splint Products, Inc.K821693J & J DIP WATER ADDITIVEJohnson & Johnson Professionals, Inc.K802522DELTA-LITE CASTING TAPE & SPLINTSJohnson & Johnson Professionals, 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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