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FDA 510(k)

IRAS EDS INTERFEROMETRIC STIMULATOR

K-Number: K873990 · 1988-02-05

ApplicantRandwal Instrument Co., Inc.
Decision Date1988-02-05
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRAS EDS INTERFEROMETRIC STIMULATOR 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 1988-02-05 under 510(k) number K873990. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRAS EDS INTERFEROMETRIC STIMULATOR?

IRAS EDS INTERFEROMETRIC STIMULATOR is a medical device that received FDA 510(k) clearance on 1988-02-05. The listed applicant is Randwal Instrument Co., Inc.. The 510(k) number is K873990.

When did IRAS EDS INTERFEROMETRIC STIMULATOR receive FDA 510(k) clearance?

IRAS EDS INTERFEROMETRIC STIMULATOR received FDA 510(k) clearance on 1988-02-05, under 510(k) number K873990.

Who is the listed applicant for IRAS EDS INTERFEROMETRIC STIMULATOR?

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 IRAS EDS INTERFEROMETRIC STIMULATOR?

The FDA product code for IRAS EDS INTERFEROMETRIC STIMULATOR is HLX.

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 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.

K873987IRAS GLARE TESTERK864012IRAS PERIMETERK853556LASER IRASK842567PORTABLE ACUIOMETERK827577VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER

Related Devices (Code: HLX)

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.

K003442MODIFICATION TO EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K983983EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K925741CLARUS ENDOSCOPIC HOOK KNIFEClarus Medical Systems, Inc.K914393RETINA TESTERRetina TesterK914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]Lkc Technologies, Inc.K853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)Biosan Laboratories, Inc.

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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