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FDA 510(k)

CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE

K-Number: K912987 · 1991-10-28

ApplicantDouglas James Donaldson Compliance Services
Decision Date1991-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE is the device name listed in this FDA 510(k) record. The listed applicant is Douglas James Donaldson Compliance Services. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K912987. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE?

CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Douglas James Donaldson Compliance Services. The 510(k) number is K912987.

When did CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE receive FDA 510(k) clearance?

CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE received FDA 510(k) clearance on 1991-10-28, under 510(k) number K912987.

Who is the listed applicant for CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE?

The FDA 510(k) record lists Douglas James Donaldson Compliance Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE?

The FDA product code for CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE is GEX. This falls under the Gastroenterology category.

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Other records listing Douglas James Donaldson Compliance Services 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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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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