510(k) clearances

EVOLVE Nitric Oxide Delivery System

Malinckrodt Manufacturing, LLC · Anesthesiology

K240410Substantially EquivalentSpecialMRN
Open FDA's page for this record
Third party flag
N
City
Madison
Advisory committee description
Anesthesiology
Address 1
6603 Femrite Dr.
Statement or summary
Summary
Product code
MRN
Zip code
53718
Applicant
Malinckrodt Manufacturing, LLC
Decision date
2024-05-28
Decision code
SESE
Country code
US
Device name
EVOLVE Nitric Oxide Delivery System
Advisory committee
AN
Contact
Jennifer Brett
K number
K240410
State
WI
Date received
2024-02-12
Review advisory committee
AN
Postal code
53718
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Apparatus, Nitric Oxide Delivery
Medical specialty description
Anesthesiology
Regulation number
868.5165
Device class
2
Registration number
2518435, 3004531588, 9611296, 3014527933, 2133810, 3012796317, 1625392, 3019771924, 3011193444, 3012160128, 3006897516
FEI number
2518435, 1000058335, 3004531588, 3000203066, 3012796317, 3019771924, 3002809568, 3011193444, 3014074925, 3012160128, 3006897516
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.