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FDA 510(k)

MAC 150E OPTHALMIC CHAIR

K-Number: K864574 · 1986-12-15

ApplicantKoken Mfg Company, Inc.
Decision Date1986-12-15
Product CodeHME
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAC 150E 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 K864574. 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 MAC 150E OPTHALMIC CHAIR?

MAC 150E 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 K864574.

When did MAC 150E OPTHALMIC CHAIR receive FDA 510(k) clearance?

MAC 150E OPTHALMIC CHAIR received FDA 510(k) clearance on 1986-12-15, under 510(k) number K864574.

Who is the listed applicant for MAC 150E 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 MAC 150E OPTHALMIC CHAIR?

The FDA product code for MAC 150E 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Koken Mfg Company, Inc. 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.

K864501KOKEN'S NEW MODEL M-3000 POWER TABLEK864494MODEL 6500 OPTHALMIC CHAIRK864325DR7700 OPERATING TABLEK864295DR.500O OPERATING TABLE

Related Devices (Code: HME)

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.

K930449MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIRMarco Ophthalmic, Inc.K914416BREATH-EASY, MODIFICATIONIcor ABK894018RELIANCE(R) 6200 EXAMINATION CHAIRReliance Medical Products, Inc.K870112STORZ ENT/OPHTHALMIC MAXI CHAIRStorz Instrument Co.K864494MODEL 6500 OPTHALMIC CHAIRKoken Mfg Company, Inc.K863728THE ERGOSYSTEM CHAIRCharles D. Bell, 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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