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FDA 510(k)

TOMEY PE-300 PORTABLE ERG

K-Number: K921815 · 1992-07-15

ApplicantTomey Corporation USA
Decision Date1992-07-15
Product CodeHLT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOMEY PE-300 PORTABLE ERG 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 1992-07-15 under 510(k) number K921815. The device is classified under product code HLT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMEY PE-300 PORTABLE ERG?

TOMEY PE-300 PORTABLE ERG is a medical device that received FDA 510(k) clearance on 1992-07-15. The listed applicant is Tomey Corporation USA. The 510(k) number is K921815.

When did TOMEY PE-300 PORTABLE ERG receive FDA 510(k) clearance?

TOMEY PE-300 PORTABLE ERG received FDA 510(k) clearance on 1992-07-15, under 510(k) number K921815.

Who is the listed applicant for TOMEY PE-300 PORTABLE ERG?

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-300 PORTABLE ERG?

The FDA product code for TOMEY PE-300 PORTABLE ERG is HLT.

Related Clinical Trials

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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 ELECTRODEK932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4K945959VIDEO VISION ANALYZER (VIVA), VRB 100K944910TOMEY EM-1000 SPECULAR MICROSCOPE

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Related Devices (Code: HLT)

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.

K924277DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDINGChalgren Enterprises, Inc.K841293PANORAMIC LOUPES - VARIOUSKeller Instruments, Inc.K781543ORBIOGRAPHSonometrics Systems, 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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