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FDA 510(k)

OPERAID NUCLEUS

K-Number: K841807 · 1984-11-21

ApplicantJedmed Instrument Co.
Decision Date1984-11-21
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPERAID NUCLEUS is the device name listed in this FDA 510(k) record. The listed applicant is Jedmed Instrument Co.. It received FDA 510(k) clearance on 1984-11-21 under 510(k) number K841807. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERAID NUCLEUS?

OPERAID NUCLEUS is a medical device that received FDA 510(k) clearance on 1984-11-21. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K841807.

When did OPERAID NUCLEUS receive FDA 510(k) clearance?

OPERAID NUCLEUS received FDA 510(k) clearance on 1984-11-21, under 510(k) number K841807.

Who is the listed applicant for OPERAID NUCLEUS?

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

What is the FDA product code for OPERAID NUCLEUS?

The FDA product code for OPERAID NUCLEUS is KYG.

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Other records listing Jedmed Instrument Co. 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.

K021750LID CHAIN EYELID WEIGHTSK954184JED-LIGHT FIBEROPTIC LIGHT SOURCEK944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)K950925JEDMED LARYNGEAL SCOPEK953457JEDMED SPECTRUM ENT CABINETK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, 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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