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FDA 510(k)

PRECISION OPTICS IMAGE COUPLER

K-Number: K903458 · 1990-10-19

ApplicantPrecise Optics
Decision Date1990-10-19
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRECISION OPTICS IMAGE COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K903458. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION OPTICS IMAGE COUPLER?

PRECISION OPTICS IMAGE COUPLER is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Precise Optics. The 510(k) number is K903458.

When did PRECISION OPTICS IMAGE COUPLER receive FDA 510(k) clearance?

PRECISION OPTICS IMAGE COUPLER received FDA 510(k) clearance on 1990-10-19, under 510(k) number K903458.

Who is the listed applicant for PRECISION OPTICS IMAGE COUPLER?

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

What is the FDA product code for PRECISION OPTICS IMAGE COUPLER?

The FDA product code for PRECISION OPTICS IMAGE COUPLER is FET.

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Other records listing Precise Optics 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.

K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMK935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERK932878PRECISION INTRA-ORAL SCOPESK914084ENDOSCOPESK914184P2020-8-0 BEAM-LIMITING DEVICEK911744PRECISION OPTICS CORPORATION LAPAROSCOPE

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Related Devices (Code: FET)

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

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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