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FDA 510(k)

BK-7505 RADIOPAQUE GONIOMETER, 8

K-Number: K801716 · 1980-08-04

Decision Date1980-08-04
Product CodeKQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BK-7505 RADIOPAQUE GONIOMETER, 8 is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801716. The device is classified under product code KQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BK-7505 RADIOPAQUE GONIOMETER, 8?

BK-7505 RADIOPAQUE GONIOMETER, 8 is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K801716.

When did BK-7505 RADIOPAQUE GONIOMETER, 8 receive FDA 510(k) clearance?

BK-7505 RADIOPAQUE GONIOMETER, 8 received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801716.

Who is the listed applicant for BK-7505 RADIOPAQUE GONIOMETER, 8?

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

What is the FDA product code for BK-7505 RADIOPAQUE GONIOMETER, 8?

The FDA product code for BK-7505 RADIOPAQUE GONIOMETER, 8 is KQW.

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 Fred Sammons, 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.

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Related Devices (Code: KQW)

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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