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FDA 510(k)

MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM

K-Number: K942233 · 1994-07-01

ApplicantCarl Zeiss, Inc.
Decision Date1994-07-01
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1994-07-01 under 510(k) number K942233. 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 MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM?

MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K942233.

When did MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM receive FDA 510(k) clearance?

MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM received FDA 510(k) clearance on 1994-07-01, under 510(k) number K942233.

Who is the listed applicant for MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM?

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

What is the FDA product code for MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM?

The FDA product code for MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM is EPT.

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Other records listing Carl Zeiss, Inc. 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.

K013402VISULAS 532SK003885VISULAS YAG IIK993357IOLMASTERK983868OPMI TWINER SURGICAL MICROSCOPEK965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEMK961380CPC PROBE

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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.

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.K860811ZEISS VOICE CONTROL SYSTEM FOR OPMI'SCarl Zeiss, 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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