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FDA 510(k)

VIDEO SCOPE SYSTEM (OTOSCOPE)

K-Number: K944031 · 1994-09-23

ApplicantJedmed Instrument Co.
Decision Date1994-09-23
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VIDEO SCOPE SYSTEM (OTOSCOPE) 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 1994-09-23 under 510(k) number K944031. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDEO SCOPE SYSTEM (OTOSCOPE)?

VIDEO SCOPE SYSTEM (OTOSCOPE) is a medical device that received FDA 510(k) clearance on 1994-09-23. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K944031.

When did VIDEO SCOPE SYSTEM (OTOSCOPE) receive FDA 510(k) clearance?

VIDEO SCOPE SYSTEM (OTOSCOPE) received FDA 510(k) clearance on 1994-09-23, under 510(k) number K944031.

Who is the listed applicant for VIDEO SCOPE SYSTEM (OTOSCOPE)?

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 VIDEO SCOPE SYSTEM (OTOSCOPE)?

The FDA product code for VIDEO SCOPE SYSTEM (OTOSCOPE) is ERA.

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.

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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

View all 91 devices →

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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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