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FDA 510(k)

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION

K-Number: K911721 · 1991-06-25

ApplicantKeeler Instruments, Inc.
Decision Date1991-06-25
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1991-06-25 under 510(k) number K911721. 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 KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION?

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-06-25. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K911721.

When did KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION receive FDA 510(k) clearance?

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION received FDA 510(k) clearance on 1991-06-25, under 510(k) number K911721.

Who is the listed applicant for KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION?

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

What is the FDA product code for KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION?

The FDA product code for KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION is HKX.

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Other records listing Keeler Instruments, 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.

K181143Keeler TonoCare TonometerK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERK093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000K100500PSL CLASSIC SLIT LAMPK062412CRYOMATICK060822VANTAGE INDIRECT OPHTHALMOSCOPE

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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

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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