Decision Date2020-10-21
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Powerpress Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Hanuri Distribution, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K202044. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Powerpress Recovery Unit?
Powerpress Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Hanuri Distribution, Inc.. The 510(k) number is K202044.
When did Powerpress Recovery Unit receive FDA 510(k) clearance?
Powerpress Recovery Unit received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202044.
Who is the listed applicant for Powerpress Recovery Unit?
The FDA 510(k) record lists Hanuri Distribution, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Powerpress Recovery Unit?
The FDA product code for Powerpress Recovery Unit is IRP.
Related Devices (Code: IRP)
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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.