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FDA 510(k)

SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS

K-Number: K894042 · 1989-08-11

ApplicantLabeltape Meditect, Inc.
Decision Date1989-08-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K894042. 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 SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS?

SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K894042.

When did SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS receive FDA 510(k) clearance?

SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS received FDA 510(k) clearance on 1989-08-11, under 510(k) number K894042.

Who is the listed applicant for SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS?

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

What is the FDA product code for SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS?

The FDA product code for SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS is GXY.

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Other records listing Labeltape Meditect, Inc. as applicant

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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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