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FDA 510(k)

OLYMPUS PK300

K-Number: K864834 · 1987-02-20

ApplicantOlympus Corp.
Decision Date1987-02-20
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS PK300 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1987-02-20 under 510(k) number K864834. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS PK300?

OLYMPUS PK300 is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is Olympus Corp.. The 510(k) number is K864834.

When did OLYMPUS PK300 receive FDA 510(k) clearance?

OLYMPUS PK300 received FDA 510(k) clearance on 1987-02-20, under 510(k) number K864834.

Who is the listed applicant for OLYMPUS PK300?

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

What is the FDA product code for OLYMPUS PK300?

The FDA product code for OLYMPUS PK300 is JJF.

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Other records listing Olympus 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.

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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