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FDA 510(k)

PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM

K-Number: K810699 · 1981-06-09

ApplicantVisidyne Corp.
Decision Date1981-06-09
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Visidyne Corp.. It received FDA 510(k) clearance on 1981-06-09 under 510(k) number K810699. 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 PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM?

PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Visidyne Corp.. The 510(k) number is K810699.

When did PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM receive FDA 510(k) clearance?

PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM received FDA 510(k) clearance on 1981-06-09, under 510(k) number K810699.

Who is the listed applicant for PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM?

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

What is the FDA product code for PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM?

The FDA product code for PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM 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 Visidyne Corp. 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.

K811316TRISCAN, MODELS 38,40,41,43 & 45K810700CHROMOPS FM-100 COLOR VISION TESTER

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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