P300 Attachment
K-Number: K202120 · 2021-10-22
ApplicantNakanishi, Inc.
Decision Date2021-10-22
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
P300 Attachment is a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2021-10-22 under approval number K202120. 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 P300 Attachment?
P300 Attachment is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Nakanishi, Inc.. The 510(k) number is K202120.
When was P300 Attachment approved by the FDA?
P300 Attachment received FDA 510(k) clearance on 2021-10-22, under approval number K202120.
What company makes P300 Attachment?
P300 Attachment is manufactured by Nakanishi, Inc..
What is the FDA product code for P300 Attachment?
The FDA product code for P300 Attachment 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.