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FDA 510(k)

FOCUSCOPE UNIVERSAL SYSTEM

K-Number: K843900 · 1984-12-06

ApplicantMedical Diagnostics, Ca.
Decision Date1984-12-06
Product CodeGDB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOCUSCOPE UNIVERSAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostics, Ca.. It received FDA 510(k) clearance on 1984-12-06 under 510(k) number K843900. The device is classified under product code GDB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUSCOPE UNIVERSAL SYSTEM?

FOCUSCOPE UNIVERSAL SYSTEM is a medical device that received FDA 510(k) clearance on 1984-12-06. The listed applicant is Medical Diagnostics, Ca.. The 510(k) number is K843900.

When did FOCUSCOPE UNIVERSAL SYSTEM receive FDA 510(k) clearance?

FOCUSCOPE UNIVERSAL SYSTEM received FDA 510(k) clearance on 1984-12-06, under 510(k) number K843900.

Who is the listed applicant for FOCUSCOPE UNIVERSAL SYSTEM?

The FDA 510(k) record lists Medical Diagnostics, Ca. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUSCOPE UNIVERSAL SYSTEM?

The FDA product code for FOCUSCOPE UNIVERSAL SYSTEM is GDB.

Related Clinical Trials

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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Other records listing Medical Diagnostics, Ca. 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.

K853140MDI QUIK TEST NARCOTICS DRUG SCREENK843343MEDICA IIF-ANTI-THYROID ANTIBODY TESTK831100MEDICA IIF-MULTIPLE ANTIBODY TEST KIT

Related Devices (Code: GDB)

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.

K032283DESIGNS FOR VISION FIBEROPTIC LIGHTDesigns For Vision, Inc.K961536FLEXSCOPEMatrix Medica, Inc.K935818ENDOSCOPECuda Products Co.K882061OLYMPUS GF-UM3/EU-M3Olympus Corp.K855151FRITCH OPHTHALMIC ENDOSCOPERegtecK810007PENTAX UPPER G.I. FIBERSCOPE, #FG-34Pentax Precision Instrument Corp.

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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