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FDA 510(k)

ENTERMED ENTUNIT

K-Number: K802712 · 1980-11-26

ApplicantJedmed Instrument Co.
Decision Date1980-11-26
Product CodeETF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTERMED ENTUNIT 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 1980-11-26 under 510(k) number K802712. The device is classified under product code ETF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERMED ENTUNIT?

ENTERMED ENTUNIT is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K802712.

When did ENTERMED ENTUNIT receive FDA 510(k) clearance?

ENTERMED ENTUNIT received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802712.

Who is the listed applicant for ENTERMED ENTUNIT?

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 ENTERMED ENTUNIT?

The FDA product code for ENTERMED ENTUNIT is ETF.

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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)K953457JEDMED SPECTRUM ENT CABINETK950925JEDMED LARYNGEAL SCOPEK950785HORTMANN AIRMATIC AIR CALORIC STIMULATOR

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Related Devices (Code: ETF)

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.

K953457JEDMED SPECTRUM ENT CABINETJedmed Instrument Co.K945395PREMIER MIRROR WARMERPremier Dental Products Co.K932470LANGGASSE 90Happersberger Otopront GmbHK911901MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCEStortzK910781#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCESMidmark Corp.K910243MOBILE TREATMENT CARTJedmed Instrument Co.

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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