510(k) clearances

NOxBOXi Nitric Oxide Delivery System

Linde Gas & Equipment, Inc. · Anesthesiology

K233251Substantially EquivalentTraditionalMRN
Open FDA's page for this record
Third party flag
N
City
Livingston
Advisory committee description
Anesthesiology
Address 1
208 W. Main St.
Statement or summary
Summary
Product code
MRN
Zip code
38570
Applicant
Linde Gas & Equipment, Inc.
Decision date
2024-05-23
Decision code
SESE
Country code
US
Device name
NOxBOXi Nitric Oxide Delivery System
Advisory committee
AN
Contact
Dave Loflin
K number
K233251
State
TN
Date received
2023-09-28
Review advisory committee
AN
Postal code
38570
Decision description
Substantially Equivalent
Clearance type
Traditional
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.