FDA 510(k)

ELAN 4 Electro Motor System

K-Number: K203739 · 2021-08-24

Decision Date2021-08-24

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ELAN 4 Electro Motor System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K203739. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELAN 4 Electro Motor System?

ELAN 4 Electro Motor System is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Aesculap, Inc.. The 510(k) number is K203739.

When did ELAN 4 Electro Motor System receive FDA 510(k) clearance?

ELAN 4 Electro Motor System received FDA 510(k) clearance on 2021-08-24, under 510(k) number K203739.

Who is the listed applicant for ELAN 4 Electro Motor System?

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

What is the FDA product code for ELAN 4 Electro Motor System?

The FDA product code for ELAN 4 Electro Motor System is HBE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.