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FDA 510(k)

COMPUTERIZED ELECTRO-OCULOGRAPH

K-Number: K790637 · 1979-08-28

ApplicantPotomac Medical System
Decision Date1979-08-28
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COMPUTERIZED ELECTRO-OCULOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Potomac Medical System. It received FDA 510(k) clearance on 1979-08-28 under 510(k) number K790637. 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 COMPUTERIZED ELECTRO-OCULOGRAPH?

COMPUTERIZED ELECTRO-OCULOGRAPH is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Potomac Medical System. The 510(k) number is K790637.

When did COMPUTERIZED ELECTRO-OCULOGRAPH receive FDA 510(k) clearance?

COMPUTERIZED ELECTRO-OCULOGRAPH received FDA 510(k) clearance on 1979-08-28, under 510(k) number K790637.

Who is the listed applicant for COMPUTERIZED ELECTRO-OCULOGRAPH?

The FDA 510(k) record lists Potomac Medical System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPUTERIZED ELECTRO-OCULOGRAPH?

The FDA product code for COMPUTERIZED ELECTRO-OCULOGRAPH 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 Potomac Medical System 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.

K851174METACHROME

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.K873990IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., Inc.

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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