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FDA 510(k)

MONOBLOCK PROSTOPERATIVE TENS ELECTRODE

K-Number: K832145 · 1983-07-19

ApplicantNew Dimensions IN Medicine, Inc.
Decision Date1983-07-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MONOBLOCK PROSTOPERATIVE TENS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is New Dimensions IN Medicine, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K832145. 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 MONOBLOCK PROSTOPERATIVE TENS ELECTRODE?

MONOBLOCK PROSTOPERATIVE TENS ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is New Dimensions IN Medicine, Inc.. The 510(k) number is K832145.

When did MONOBLOCK PROSTOPERATIVE TENS ELECTRODE receive FDA 510(k) clearance?

MONOBLOCK PROSTOPERATIVE TENS ELECTRODE received FDA 510(k) clearance on 1983-07-19, under 510(k) number K832145.

Who is the listed applicant for MONOBLOCK PROSTOPERATIVE TENS ELECTRODE?

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

What is the FDA product code for MONOBLOCK PROSTOPERATIVE TENS ELECTRODE?

The FDA product code for MONOBLOCK PROSTOPERATIVE TENS ELECTRODE is GXY.

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Other records listing New Dimensions IN Medicine, Inc. as applicant

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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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