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FDA 510(k)

OPUS I OPTION - FIBER OPTIC L SYSTEM

K-Number: K761331 · 1977-01-03

ApplicantSyntex Corp.
Decision Date1977-01-03
Product CodeEAY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPUS I OPTION - FIBER OPTIC L SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1977-01-03 under 510(k) number K761331. The device is classified under product code EAY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS I OPTION - FIBER OPTIC L SYSTEM?

OPUS I OPTION - FIBER OPTIC L SYSTEM is a medical device that received FDA 510(k) clearance on 1977-01-03. The listed applicant is Syntex Corp.. The 510(k) number is K761331.

When did OPUS I OPTION - FIBER OPTIC L SYSTEM receive FDA 510(k) clearance?

OPUS I OPTION - FIBER OPTIC L SYSTEM received FDA 510(k) clearance on 1977-01-03, under 510(k) number K761331.

Who is the listed applicant for OPUS I OPTION - FIBER OPTIC L SYSTEM?

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

What is the FDA product code for OPUS I OPTION - FIBER OPTIC L SYSTEM?

The FDA product code for OPUS I OPTION - FIBER OPTIC L SYSTEM is EAY.

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Other records listing Syntex 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.

K920314TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)K843593SURGIPRESS SURGICAL LOOPK780997AMALGAM ALLOYK780769S-100 CT SCANNERK780483FIBER OPTIC HANDPIECEK761332HI-SENSITIVITY MODE OPTION FOR S60-1A

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Related Devices (Code: EAY)

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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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