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FDA 510(k)

AMBLYOPIA TRAINER

K-Number: K800112 · 1980-03-10

ApplicantLife-Tech Instruments, Inc.
Decision Date1980-03-10
Product CodeHPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMBLYOPIA TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Instruments, Inc.. It received FDA 510(k) clearance on 1980-03-10 under 510(k) number K800112. The device is classified under product code HPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBLYOPIA TRAINER?

AMBLYOPIA TRAINER is a medical device that received FDA 510(k) clearance on 1980-03-10. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K800112.

When did AMBLYOPIA TRAINER receive FDA 510(k) clearance?

AMBLYOPIA TRAINER received FDA 510(k) clearance on 1980-03-10, under 510(k) number K800112.

Who is the listed applicant for AMBLYOPIA TRAINER?

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

What is the FDA product code for AMBLYOPIA TRAINER?

The FDA product code for AMBLYOPIA TRAINER is HPL.

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Other records listing Life-Tech 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.

K812177LIFE-TECH #1857 PRESSURE/POLOT MODULEK812179LIFE-TECH #1753 BIOFEEDBACK TRAINERK812180LIFE-TECH #5102 VISULABK812178LIFE-TECH #'S 1106/1156 UROLABSK790663MODEL 1750 STANDING URINALK790664MODEL 1309 AUDIO MONITOR

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Related Devices (Code: HPL)

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.

K931731STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERYStorz Instrument Co.K933739360 DEGREE FIXATION LIGHTVaritronicsK873914ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)Richmond Products, Inc.K854383KERATOLUXCarl Zeiss, Inc.K801381FITE FIXATION TOY FOR OCULAR EXAMFite Engineering Corp.K781313VISION-STIMULATOR, CAMClement Clarke, 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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