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FDA 510(k)

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

K-Number: K010998 · 2001-06-27

ApplicantLangham Ophthalmic Technologies
Decision Date2001-06-27
Product CodeHKX
Advisory CommitteeOP
DecisionUnknown

Device Summary

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 is the device name listed in this FDA 510(k) record. The listed applicant is Langham Ophthalmic Technologies. It received FDA 510(k) clearance on 2001-06-27 under 510(k) number K010998. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201?

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Langham Ophthalmic Technologies. The 510(k) number is K010998.

When did LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 receive FDA 510(k) clearance?

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 received FDA 510(k) clearance on 2001-06-27, under 510(k) number K010998.

Who is the listed applicant for LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201?

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

What is the FDA product code for LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201?

The FDA product code for LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 is HKX.

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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 CorporationK223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany ElamedK181260MiiS 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.

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