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FDA 510(k)

LENSCHEK

K-Number: K944022 · 1994-11-17

ApplicantLeica, Inc.
Decision Date1994-11-17
Product CodeHLM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSCHEK is the device name listed in this FDA 510(k) record. The listed applicant is Leica, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K944022. The device is classified under product code HLM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENSCHEK?

LENSCHEK is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Leica, Inc.. The 510(k) number is K944022.

When did LENSCHEK receive FDA 510(k) clearance?

LENSCHEK received FDA 510(k) clearance on 1994-11-17, under 510(k) number K944022.

Who is the listed applicant for LENSCHEK?

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

What is the FDA product code for LENSCHEK?

The FDA product code for LENSCHEK is HLM.

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 Leica, 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.

K951054XCEL SLIT LAMPK922770UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311

Related Devices (Code: HLM)

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.

K940997AL-3300Hoya Corp. USAK936199AUTOMATIC LENSOMETERCanon USA, Inc.K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.K924776BURTON LENSMETER - MODEL 2021R.H. Burton Co.K924785BURTON RADIUSGAUGE - MODEL 2030R.H. Burton Co.

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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