Mercy babyTAPE
K-Number: K191174 · 2019-10-10
ApplicantChildren'S Mercy Hospital
Decision Date2019-10-10
Product CodePIR
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Mercy babyTAPE is the device name listed in this FDA 510(k) record. The listed applicant is Children'S Mercy Hospital. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K191174. The device is classified under product code PIR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mercy babyTAPE?
Mercy babyTAPE is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Children'S Mercy Hospital. The 510(k) number is K191174.
When did Mercy babyTAPE receive FDA 510(k) clearance?
Mercy babyTAPE received FDA 510(k) clearance on 2019-10-10, under 510(k) number K191174.
Who is the listed applicant for Mercy babyTAPE?
The FDA 510(k) record lists Children'S Mercy Hospital as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mercy babyTAPE?
The FDA product code for Mercy babyTAPE is PIR.
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.