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FDA 510(k)

ENTHERMO IRRIGATION UNIT

K-Number: K863615 · 1986-12-16

ApplicantJedmed Instrument Co.
Decision Date1986-12-16
Product CodeETP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTHERMO IRRIGATION UNIT 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 1986-12-16 under 510(k) number K863615. The device is classified under product code ETP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTHERMO IRRIGATION UNIT?

ENTHERMO IRRIGATION UNIT is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K863615.

When did ENTHERMO IRRIGATION UNIT receive FDA 510(k) clearance?

ENTHERMO IRRIGATION UNIT received FDA 510(k) clearance on 1986-12-16, under 510(k) number K863615.

Who is the listed applicant for ENTHERMO IRRIGATION UNIT?

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 ENTHERMO IRRIGATION UNIT?

The FDA product code for ENTHERMO IRRIGATION UNIT is ETP.

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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: ETP)

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.

K820775VESTIBULARISETJedmed Instrument Co.K821481NASAL-THROAT SPRAY IRRIGATION INSTRUM.Ethicare ProductsK813552MODEL 3000C CALORIC IRRIGATORLife-Tech Intl., Inc.K800443HYGROTHERMJedmed Instrument Co.K800442VARIOTHERMJedmed 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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