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FDA 510(k)

ZEISS VOICE CONTROL SYSTEM FOR OPMI'S

K-Number: K860811 · 1986-04-30

ApplicantCarl Zeiss, Inc.
Decision Date1986-04-30
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZEISS VOICE CONTROL SYSTEM FOR OPMI'S 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 1986-04-30 under 510(k) number K860811. 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 ZEISS VOICE CONTROL SYSTEM FOR OPMI'S?

ZEISS VOICE CONTROL SYSTEM FOR OPMI'S is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K860811.

When did ZEISS VOICE CONTROL SYSTEM FOR OPMI'S receive FDA 510(k) clearance?

ZEISS VOICE CONTROL SYSTEM FOR OPMI'S received FDA 510(k) clearance on 1986-04-30, under 510(k) number K860811.

Who is the listed applicant for ZEISS VOICE CONTROL SYSTEM FOR OPMI'S?

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 ZEISS VOICE CONTROL SYSTEM FOR OPMI'S?

The FDA product code for ZEISS VOICE CONTROL SYSTEM FOR OPMI'S 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.

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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