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FDA 510(k)

ELECTRONIC UNIT

K-Number: K832887 · 1983-10-04

ApplicantSurgi-Quip Inc.U
Decision Date1983-10-04
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgi-Quip Inc.U. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832887. 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 ELECTRONIC UNIT?

ELECTRONIC UNIT is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Surgi-Quip Inc.U. The 510(k) number is K832887.

When did ELECTRONIC UNIT receive FDA 510(k) clearance?

ELECTRONIC UNIT received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832887.

Who is the listed applicant for ELECTRONIC UNIT?

The FDA 510(k) record lists Surgi-Quip Inc.U as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRONIC UNIT?

The FDA product code for ELECTRONIC UNIT is EPT.

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Other records listing Surgi-Quip Inc.U 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.

K841115CHARLES/MCINTYRE GIANT BREAK TABLEK841116MOBILE OPHTHALMIC OPERATING TABLEK840004WEE BAG O'MERCURYK822554CEMENT EXTRACTION INSTRUMENTATIONK822427SELF-CONTAINED MOBILE OPHTHAL. OPER. .K822428SURGI-QUIP MICROSCOPE STAND

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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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