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FDA 510(k)

FISCH DRILL SYSTEM

K-Number: K792159 · 1979-11-27

ApplicantJedmed Instrument Co.
Decision Date1979-11-27
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FISCH DRILL SYSTEM 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 1979-11-27 under 510(k) number K792159. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISCH DRILL SYSTEM?

FISCH DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K792159.

When did FISCH DRILL SYSTEM receive FDA 510(k) clearance?

FISCH DRILL SYSTEM received FDA 510(k) clearance on 1979-11-27, under 510(k) number K792159.

Who is the listed applicant for FISCH DRILL SYSTEM?

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 FISCH DRILL SYSTEM?

The FDA product code for FISCH DRILL SYSTEM is ERL.

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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: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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