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FDA 510(k)

PORTABLE ACUIOMETER

K-Number: K842567 · 1984-08-15

ApplicantRandwal Instrument Co., Inc.
Decision Date1984-08-15
Product CodeHLJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PORTABLE ACUIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Randwal Instrument Co., Inc.. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K842567. 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 PORTABLE ACUIOMETER?

PORTABLE ACUIOMETER is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Randwal Instrument Co., Inc.. The 510(k) number is K842567.

When did PORTABLE ACUIOMETER receive FDA 510(k) clearance?

PORTABLE ACUIOMETER received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842567.

Who is the listed applicant for PORTABLE ACUIOMETER?

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

What is the FDA product code for PORTABLE ACUIOMETER?

The FDA product code for PORTABLE ACUIOMETER is HLJ.

Related Clinical Trials

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Other records listing Randwal Instrument Co., 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.

K873990IRAS EDS INTERFEROMETRIC STIMULATORK873987IRAS GLARE TESTERK864012IRAS PERIMETERK853556LASER IRASK827577VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER

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

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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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