CPR BAND
K-Number: K201581 · 2021-03-06
ApplicantCredo
Decision Date2021-03-06
Product CodeLIX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CPR BAND is the device name listed in this FDA 510(k) record. The listed applicant is Credo. It received FDA 510(k) clearance on 2021-03-06 under 510(k) number K201581. The device is classified under product code LIX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CPR BAND?
CPR BAND is a medical device that received FDA 510(k) clearance on 2021-03-06. The listed applicant is Credo. The 510(k) number is K201581.
When did CPR BAND receive FDA 510(k) clearance?
CPR BAND received FDA 510(k) clearance on 2021-03-06, under 510(k) number K201581.
Who is the listed applicant for CPR BAND?
The FDA 510(k) record lists Credo as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CPR BAND?
The FDA product code for CPR BAND is LIX.
Related Devices (Code: LIX)
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
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