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FDA 510(k)

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2

K-Number: K944207 · 1994-12-07

ApplicantComputed Anatomy, Inc.
Decision Date1994-12-07
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 is the device name listed in this FDA 510(k) record. The listed applicant is Computed Anatomy, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K944207. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPOGRAPHIC MODELING SYSTEM 2 TMS-2?

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Computed Anatomy, Inc.. The 510(k) number is K944207.

When did TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 receive FDA 510(k) clearance?

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 received FDA 510(k) clearance on 1994-12-07, under 510(k) number K944207.

Who is the listed applicant for TOPOGRAPHIC MODELING SYSTEM 2 TMS-2?

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

What is the FDA product code for TOPOGRAPHIC MODELING SYSTEM 2 TMS-2?

The FDA product code for TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 is HLQ.

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 Computed Anatomy, 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.

K902012VKS-1 VIDEO KERATOSCOPEK901363TOPOGRAPHIC MODELING SYSTEMK862379CORNEAL MODELING SYSTEM

Related Devices (Code: HLQ)

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.

K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000Nidek Co., Ltd.K973756EYE SYS VISTAEyesys Technologies, Inc.K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical MarketinigK940647ORBSCAN(TM) KERATOMETEROrbtek, Inc.

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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