ELAN 4 Air Motor System
K-Number: K172907 · 2018-11-09
ApplicantAesculap, Inc.
Decision Date2018-11-09
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ELAN 4 Air Motor System is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2018-11-09 under approval number K172907. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ELAN 4 Air Motor System?
ELAN 4 Air Motor System is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by Aesculap, Inc.. The 510(k) number is K172907.
When was ELAN 4 Air Motor System approved by the FDA?
ELAN 4 Air Motor System received FDA 510(k) clearance on 2018-11-09, under approval number K172907.
What company makes ELAN 4 Air Motor System?
ELAN 4 Air Motor System is manufactured by Aesculap, Inc..
What is the FDA product code for ELAN 4 Air Motor System?
The FDA product code for ELAN 4 Air Motor System is HBB.
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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.