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FDA 510(k)

COLLI-MATETM MODEL NO. B800

K-Number: K874687 · 1987-12-30

ApplicantSummit Industries, Inc.
Decision Date1987-12-30
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLLI-MATETM MODEL NO. B800 is the device name listed in this FDA 510(k) record. The listed applicant is Summit Industries, Inc.. It received FDA 510(k) clearance on 1987-12-30 under 510(k) number K874687. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLI-MATETM MODEL NO. B800?

COLLI-MATETM MODEL NO. B800 is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Summit Industries, Inc.. The 510(k) number is K874687.

When did COLLI-MATETM MODEL NO. B800 receive FDA 510(k) clearance?

COLLI-MATETM MODEL NO. B800 received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874687.

Who is the listed applicant for COLLI-MATETM MODEL NO. B800?

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

What is the FDA product code for COLLI-MATETM MODEL NO. B800?

The FDA product code for COLLI-MATETM MODEL NO. B800 is IZX.

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Other records listing Summit Industries, 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.

K874908C900 X-RAY FILM PROCESSORK851440RDIOGRAPHIC WALL HOLDER OR FILM RECEPTORK850198FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOGK850117XMA 325 (X-RAY GENERATOR)K850118XMA INTEGRATED TABLE

Related Devices (Code: IZX)

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K974240LIGHTLINE-MWuestec 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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