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FDA 510(k)

SYNTEX SYSTEM 6000

K-Number: K761330 · 1976-12-30

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

Device Summary

SYNTEX SYSTEM 6000 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 K761330. 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 SYNTEX SYSTEM 6000?

SYNTEX SYSTEM 6000 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 K761330.

When did SYNTEX SYSTEM 6000 receive FDA 510(k) clearance?

SYNTEX SYSTEM 6000 received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761330.

Who is the listed applicant for SYNTEX SYSTEM 6000?

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 SYNTEX SYSTEM 6000?

The FDA product code for SYNTEX SYSTEM 6000 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)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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