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FDA 510(k)

TOMEY DTL ELECTRODE

K-Number: K961805 · 1997-05-09

ApplicantTomey Corporation USA
Decision Date1997-05-09
Product CodeHLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOMEY DTL ELECTRODE 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 1997-05-09 under 510(k) number K961805. The device is classified under product code HLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMEY DTL ELECTRODE?

TOMEY DTL ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Tomey Corporation USA. The 510(k) number is K961805.

When did TOMEY DTL ELECTRODE receive FDA 510(k) clearance?

TOMEY DTL ELECTRODE received FDA 510(k) clearance on 1997-05-09, under 510(k) number K961805.

Who is the listed applicant for TOMEY DTL ELECTRODE?

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 DTL ELECTRODE?

The FDA product code for TOMEY DTL ELECTRODE is HLZ.

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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 SYSTEMK932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4K945959VIDEO VISION ANALYZER (VIVA), VRB 100K944910TOMEY EM-1000 SPECULAR MICROSCOPEK924760TOMEY PROTON TONOMETER

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Related Devices (Code: HLZ)

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.

K253586RM Electrode (RMH 25-01)Retmap, Inc.K232273RM Electrode (RMH 23-01)Retmap, Inc.K926540SOPHER AND BIERER OVUM FORCEPSThomasville Medical Assoc.K913239GOLDLENS(TM)Doran Instruments, Inc.K844409DTL ELECTRODESauquoit Industries, Inc.K830557ERG-JET ELECTRODEUniverso S.A.

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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