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FDA 510(k)

STERILE TREATMENT ELECTRODE

K-Number: K941923 · 1995-06-02

ApplicantStaodyne, Inc.
Decision Date1995-06-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STERILE TREATMENT ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K941923. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE TREATMENT ELECTRODE?

STERILE TREATMENT ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Staodyne, Inc.. The 510(k) number is K941923.

When did STERILE TREATMENT ELECTRODE receive FDA 510(k) clearance?

STERILE TREATMENT ELECTRODE received FDA 510(k) clearance on 1995-06-02, under 510(k) number K941923.

Who is the listed applicant for STERILE TREATMENT ELECTRODE?

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

What is the FDA product code for STERILE TREATMENT ELECTRODE?

The FDA product code for STERILE TREATMENT ELECTRODE is GZJ.

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Other records listing Staodyne, Inc. 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.

K952680VARAPULSE-2K931925TPK CUTANEOUS ELECTRODEK926510STAODYN EMS+2K931424MAXIMA IK930865STAODYN MAXIMA IIIK925898MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS

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Related Devices (Code: GZJ)

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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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