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FDA 510(k)

ELAN 4 Electro Motor System

K-Number: K203739 · 2021-08-24

ApplicantAesculap, Inc.
Decision Date2021-08-24
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELAN 4 Electro Motor System is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2021-08-24 under approval 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. It is manufactured by Aesculap, Inc.. The 510(k) number is K203739.

When was ELAN 4 Electro Motor System approved by the FDA?

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

What company makes ELAN 4 Electro Motor System?

ELAN 4 Electro Motor System is manufactured by Aesculap, Inc..

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

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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