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FDA 510(k)

MICRODYNE OFFICE SURGICAL MICROSCOPE

K-Number: K931284 · 1993-11-18

ApplicantMicrodyne, Inc.
Decision Date1993-11-18
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRODYNE OFFICE SURGICAL MICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Microdyne, Inc.. It received FDA 510(k) clearance on 1993-11-18 under 510(k) number K931284. 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 MICRODYNE OFFICE SURGICAL MICROSCOPE?

MICRODYNE OFFICE SURGICAL MICROSCOPE is a medical device that received FDA 510(k) clearance on 1993-11-18. The listed applicant is Microdyne, Inc.. The 510(k) number is K931284.

When did MICRODYNE OFFICE SURGICAL MICROSCOPE receive FDA 510(k) clearance?

MICRODYNE OFFICE SURGICAL MICROSCOPE received FDA 510(k) clearance on 1993-11-18, under 510(k) number K931284.

Who is the listed applicant for MICRODYNE OFFICE SURGICAL MICROSCOPE?

The FDA 510(k) record lists Microdyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRODYNE OFFICE SURGICAL MICROSCOPE?

The FDA product code for MICRODYNE OFFICE SURGICAL MICROSCOPE is EPT.

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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.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.K860811ZEISS VOICE CONTROL SYSTEM FOR OPMI'SCarl Zeiss, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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