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FDA 510(k)

COMPUTERIZED PUPIL

K-Number: K920937 · 1992-10-02

ApplicantTrek Medical Products, Inc.
Decision Date1992-10-02
Product CodeHLG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COMPUTERIZED PUPIL is the device name listed in this FDA 510(k) record. The listed applicant is Trek Medical Products, Inc.. It received FDA 510(k) clearance on 1992-10-02 under 510(k) number K920937. The device is classified under product code HLG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTERIZED PUPIL?

COMPUTERIZED PUPIL is a medical device that received FDA 510(k) clearance on 1992-10-02. The listed applicant is Trek Medical Products, Inc.. The 510(k) number is K920937.

When did COMPUTERIZED PUPIL receive FDA 510(k) clearance?

COMPUTERIZED PUPIL received FDA 510(k) clearance on 1992-10-02, under 510(k) number K920937.

Who is the listed applicant for COMPUTERIZED PUPIL?

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

What is the FDA product code for COMPUTERIZED PUPIL?

The FDA product code for COMPUTERIZED PUPIL is HLG.

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 Trek Medical Products, 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.

K920944FTS-200 GAS SYSTEMK900808RAPID AUTOMATIC PNEUMOPERITONEUM-IK902784FIBER OPTIC LIGHT SOURCEK895813GLAUCOMA MECHANICAL TREPHINEK882403OPHTHALMIC FLUID INJECTORK875195OPHTHALMIC LIGHT PIPE PICK

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Related Devices (Code: HLG)

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.

K895609PUPIL PATHWAY ANALYZER (PPA)Pulse Medical InstrumentsK802351F110 PHOTO BINOCULAR OPHTHALMOSCOPEMinami, Tomine & Lew

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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