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FDA 510(k)

HI-SENSITIVITY MODE OPTION FOR S60-1A

K-Number: K761332 · 1976-12-30

ApplicantSyntex Corp.
Decision Date1976-12-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HI-SENSITIVITY MODE OPTION FOR S60-1A is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761332. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-SENSITIVITY MODE OPTION FOR S60-1A?

HI-SENSITIVITY MODE OPTION FOR S60-1A is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Syntex Corp.. The 510(k) number is K761332.

When did HI-SENSITIVITY MODE OPTION FOR S60-1A receive FDA 510(k) clearance?

HI-SENSITIVITY MODE OPTION FOR S60-1A received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761332.

Who is the listed applicant for HI-SENSITIVITY MODE OPTION FOR S60-1A?

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 HI-SENSITIVITY MODE OPTION FOR S60-1A?

The FDA product code for HI-SENSITIVITY MODE OPTION FOR S60-1A is JAK.

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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 HANDPIECEK761331OPUS I OPTION - FIBER OPTIC L SYSTEM

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Related Devices (Code: JAK)

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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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