ENT EM
K-Number: K223734 · 2023-04-27
Device Summary
Frequently Asked Questions
What is the ENT EM?
ENT EM is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Brainlab AG. The 510(k) number is K223734.
When did ENT EM receive FDA 510(k) clearance?
ENT EM received FDA 510(k) clearance on 2023-04-27, under 510(k) number K223734.
Who is the listed applicant for ENT EM?
The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENT EM?
The FDA product code for ENT EM is PGW.
Related Clinical Trials
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.
Other records listing Brainlab AG as applicant
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.
Related Devices (Code: PGW)
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.
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.