FDA 510(k)

TGDC-01 PRA

K-Number: K021937 · 2002-10-11

Decision Date2002-10-11

Product CodeHKX

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

TGDC-01 PRA is the device name listed in this FDA 510(k) record. The listed applicant is Truevision Instruments. It received FDA 510(k) clearance on 2002-10-11 under 510(k) number K021937. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TGDC-01 PRA?

TGDC-01 PRA is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Truevision Instruments. The 510(k) number is K021937.

When did TGDC-01 PRA receive FDA 510(k) clearance?

TGDC-01 PRA received FDA 510(k) clearance on 2002-10-11, under 510(k) number K021937.

Who is the listed applicant for TGDC-01 PRA?

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

What is the FDA product code for TGDC-01 PRA?

The FDA product code for TGDC-01 PRA is HKX.

Related Devices (Code: HKX)

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.

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon Corporation K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany Elamed K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation

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.