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FDA 510(k)

MACULOSCOPE(TM)

K-Number: K863956 · 1986-11-13

ApplicantDoran Instruments, Inc.
Decision Date1986-11-13
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MACULOSCOPE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Doran Instruments, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K863956. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACULOSCOPE(TM)?

MACULOSCOPE(TM) is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Doran Instruments, Inc.. The 510(k) number is K863956.

When did MACULOSCOPE(TM) receive FDA 510(k) clearance?

MACULOSCOPE(TM) received FDA 510(k) clearance on 1986-11-13, under 510(k) number K863956.

Who is the listed applicant for MACULOSCOPE(TM)?

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

What is the FDA product code for MACULOSCOPE(TM)?

The FDA product code for MACULOSCOPE(TM) is GWE.

Related Clinical Trials

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.

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Other records listing Doran Instruments, 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.

K913239GOLDLENS(TM)

Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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