Cranial EM System
K-Number: K213989 · 2022-09-08
ApplicantBrainlab AG
Decision Date2022-09-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cranial EM System is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2022-09-08 under approval number K213989. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cranial EM System?
Cranial EM System is a medical device that received FDA 510(k) clearance on 2022-09-08. It is manufactured by Brainlab AG. The 510(k) number is K213989.
When was Cranial EM System approved by the FDA?
Cranial EM System received FDA 510(k) clearance on 2022-09-08, under approval number K213989.
What company makes Cranial EM System?
Cranial EM System is manufactured by Brainlab AG.
What is the FDA product code for Cranial EM System?
The FDA product code for Cranial EM System is HAW.
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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.