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FDA 510(k)

KEELER SPECTRA INDIRECT OPHTHALMOSCOPE

K-Number: K970029 · 1997-04-02

ApplicantKeeler Instruments, Inc.
Decision Date1997-04-02
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER SPECTRA INDIRECT OPHTHALMOSCOPE 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 1997-04-02 under 510(k) number K970029. The device is classified under product code HLJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEELER SPECTRA INDIRECT OPHTHALMOSCOPE?

KEELER SPECTRA INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K970029.

When did KEELER SPECTRA INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

KEELER SPECTRA INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970029.

Who is the listed applicant for KEELER SPECTRA INDIRECT OPHTHALMOSCOPE?

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 SPECTRA INDIRECT OPHTHALMOSCOPE?

The FDA product code for KEELER SPECTRA INDIRECT OPHTHALMOSCOPE is HLJ.

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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: HLJ)

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.

K131961HEINE BETA 200(R) OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITSMedical Devices (Pvt) , Ltd.K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.KgK05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25ASuzhou 66 Vision Tech Co., Ltd.

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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