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FDA 510(k)

PALPATION ENHANCER

K-Number: K801811 · 1980-09-09

ApplicantMedical Horizons Co.
Decision Date1980-09-09
Product CodeLDE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALPATION ENHANCER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Horizons Co.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801811. The device is classified under product code LDE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALPATION ENHANCER?

PALPATION ENHANCER is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Medical Horizons Co.. The 510(k) number is K801811.

When did PALPATION ENHANCER receive FDA 510(k) clearance?

PALPATION ENHANCER received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801811.

Who is the listed applicant for PALPATION ENHANCER?

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

What is the FDA product code for PALPATION ENHANCER?

The FDA product code for PALPATION ENHANCER is LDE.

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Related Devices (Code: LDE)

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

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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