FDA 510(k)

MODEL 6500 OPTHALMIC CHAIR

K-Number: K864494 · 1986-12-15

Decision Date1986-12-15

Product CodeHME

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MODEL 6500 OPTHALMIC CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Koken Mfg Company, Inc.. It received FDA 510(k) clearance on 1986-12-15 under 510(k) number K864494. The device is classified under product code HME. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 6500 OPTHALMIC CHAIR?

MODEL 6500 OPTHALMIC CHAIR is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Koken Mfg Company, Inc.. The 510(k) number is K864494.

When did MODEL 6500 OPTHALMIC CHAIR receive FDA 510(k) clearance?

MODEL 6500 OPTHALMIC CHAIR received FDA 510(k) clearance on 1986-12-15, under 510(k) number K864494.

Who is the listed applicant for MODEL 6500 OPTHALMIC CHAIR?

The FDA 510(k) record lists Koken Mfg Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 6500 OPTHALMIC CHAIR?

The FDA product code for MODEL 6500 OPTHALMIC CHAIR is HME.

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 Koken Mfg Company, Inc. as applicant

K864501KOKEN'S NEW MODEL M-3000 POWER TABLE K864574MAC 150E OPTHALMIC CHAIR K864325DR7700 OPERATING TABLE K864295DR.500O OPERATING TABLE

Related Devices (Code: HME)

K930449MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIRMarco Ophthalmic, Inc.K914416BREATH-EASY, MODIFICATIONIcor AB K894018RELIANCE(R) 6200 EXAMINATION CHAIRReliance Medical Products, Inc.K870112STORZ ENT/OPHTHALMIC MAXI CHAIRStorz Instrument Co.K864574MAC 150E OPTHALMIC CHAIRKoken Mfg Company, Inc.K863728THE ERGOSYSTEM CHAIRCharles D. Bell, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.