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FDA 510(k)

EUROMED S-601

K-Number: K862765 · 1986-08-06

ApplicantLectec Corp.
Decision Date1986-08-06
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EUROMED S-601 is the device name listed in this FDA 510(k) record. The listed applicant is Lectec Corp.. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K862765. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROMED S-601?

EUROMED S-601 is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Lectec Corp.. The 510(k) number is K862765.

When did EUROMED S-601 receive FDA 510(k) clearance?

EUROMED S-601 received FDA 510(k) clearance on 1986-08-06, under 510(k) number K862765.

Who is the listed applicant for EUROMED S-601?

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

What is the FDA product code for EUROMED S-601?

The FDA product code for EUROMED S-601 is DRX.

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Other records listing Lectec Corp. as applicant

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Related Devices (Code: DRX)

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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