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FDA 510(k)

MICROSCOPE MODEL OM-U

K-Number: K802904 · 1981-02-04

ApplicantJedmed Instrument Co.
Decision Date1981-02-04
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROSCOPE MODEL OM-U 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 1981-02-04 under 510(k) number K802904. The device is classified under product code EPT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCOPE MODEL OM-U?

MICROSCOPE MODEL OM-U is a medical device that received FDA 510(k) clearance on 1981-02-04. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K802904.

When did MICROSCOPE MODEL OM-U receive FDA 510(k) clearance?

MICROSCOPE MODEL OM-U received FDA 510(k) clearance on 1981-02-04, under 510(k) number K802904.

Who is the listed applicant for MICROSCOPE MODEL OM-U?

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 MICROSCOPE MODEL OM-U?

The FDA product code for MICROSCOPE MODEL OM-U is EPT.

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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: EPT)

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.

K942233MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEMCarl Zeiss, Inc.K931284MICRODYNE OFFICE SURGICAL MICROSCOPEMicrodyne, Inc.K933310MICRINS CONTRAST BACKGROUND MATERIALMicrins Surgical, Inc.K903412STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.Storz Instrument Co.K883581OPMI CSCarl Zeiss, Inc.K882269STORZ DIAGNOSTIC MICROSCOPE SYSTEMStorz 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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