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FDA 510(k)

APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE

K-Number: K955014 · 1996-01-26

ApplicantApplied Optronics Corp.
Decision Date1996-01-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Optronics Corp.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K955014. 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 APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE?

APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Applied Optronics Corp.. The 510(k) number is K955014.

When did APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE receive FDA 510(k) clearance?

APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE received FDA 510(k) clearance on 1996-01-26, under 510(k) number K955014.

Who is the listed applicant for APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE?

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

What is the FDA product code for APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE?

The FDA product code for APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE is GEX. This falls under the Gastroenterology category.

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Other records listing Applied Optronics 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.

K961705AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEMK961710AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEMK955007APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM

Related Devices (Code: GEX)

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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