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FDA 510(k)

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4

K-Number: K932571 · 1995-08-31

ApplicantTomey Corporation USA
Decision Date1995-08-31
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation USA. It received FDA 510(k) clearance on 1995-08-31 under 510(k) number K932571. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4?

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 is a medical device that received FDA 510(k) clearance on 1995-08-31. The listed applicant is Tomey Corporation USA. The 510(k) number is K932571.

When did TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 receive FDA 510(k) clearance?

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 received FDA 510(k) clearance on 1995-08-31, under 510(k) number K932571.

Who is the listed applicant for TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4?

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

What is the FDA product code for TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4?

The FDA product code for TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 is GWE.

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Other records listing Tomey Corporation USA 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.

K971953CONFOSCANK971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEMK961805TOMEY DTL ELECTRODEK945959VIDEO VISION ANALYZER (VIVA), VRB 100K944910TOMEY EM-1000 SPECULAR MICROSCOPEK924760TOMEY PROTON TONOMETER

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Related Devices (Code: GWE)

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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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