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FDA 510(k)

OPTEC 1000 DMV

K-Number: K863509 · 1986-11-10

ApplicantStereo Optical Co., Inc.
Decision Date1986-11-10
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTEC 1000 DMV is the device name listed in this FDA 510(k) record. The listed applicant is Stereo Optical Co., Inc.. It received FDA 510(k) clearance on 1986-11-10 under 510(k) number K863509. The device is classified under product code HOX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTEC 1000 DMV?

OPTEC 1000 DMV is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Stereo Optical Co., Inc.. The 510(k) number is K863509.

When did OPTEC 1000 DMV receive FDA 510(k) clearance?

OPTEC 1000 DMV received FDA 510(k) clearance on 1986-11-10, under 510(k) number K863509.

Who is the listed applicant for OPTEC 1000 DMV?

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

What is the FDA product code for OPTEC 1000 DMV?

The FDA product code for OPTEC 1000 DMV is HOX.

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 Stereo Optical Co., 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.

K924741OPTEC 3000K904828OPTEC 2300 AFVT, ARMED FORCES VISION TESTERK875237OPTEC 1000 DMV VISION TESTER MODIFYK843042VISION TESTER

Related Devices (Code: HOX)

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.

K100095CENTRAL VISION ANALYZER MODEL 1000Vimetrics,Llc.K944156HEINE LAMBDA 100Heine USA , Ltd.K881971OCCU-TECH VISION TESTApplied Vision Concepts, Inc.K883337PL 20/20 INFANT VISION TESTEROptimed Technologies, Inc.K882634VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREVistech Consultants, Inc.K881358PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAMNeuroscientific Corp.

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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