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FDA 510(k)

ECLIPSE SELF ADHERING ELECTRODE

K-Number: K850646 · 1985-09-03

ApplicantTodd Medical, Inc.
Decision Date1985-09-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECLIPSE SELF ADHERING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Todd Medical, Inc.. It received FDA 510(k) clearance on 1985-09-03 under 510(k) number K850646. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE SELF ADHERING ELECTRODE?

ECLIPSE SELF ADHERING ELECTRODE is a medical device that received FDA 510(k) clearance on 1985-09-03. The listed applicant is Todd Medical, Inc.. The 510(k) number is K850646.

When did ECLIPSE SELF ADHERING ELECTRODE receive FDA 510(k) clearance?

ECLIPSE SELF ADHERING ELECTRODE received FDA 510(k) clearance on 1985-09-03, under 510(k) number K850646.

Who is the listed applicant for ECLIPSE SELF ADHERING ELECTRODE?

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

What is the FDA product code for ECLIPSE SELF ADHERING ELECTRODE?

The FDA product code for ECLIPSE SELF ADHERING ELECTRODE is GXY.

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Other records listing Todd Medical, 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.

K873288CLOSED FOLEY CATHETER SYSTEMK873499TODD MEDICAL/SKILLED CARE PRODUCTSK873287IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)K873469TODD MEDICAL/SKILLED CARE PRODUCTSK850004TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF

Related Devices (Code: GXY)

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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Official Source

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