510(k) clearances

ICS Dizcovery (1091)

Natus Medical Denmark Aps · Neurology

K242198Substantially EquivalentTraditionalGWN
Open FDA's page for this record
Third party flag
N
City
Taastrup
Advisory committee description
Neurology
Address 1
Hoerskaetten 9
Statement or summary
Summary
Product code
GWN
Zip code
DK-2630
Applicant
Natus Medical Denmark Aps
Decision date
2025-02-14
Decision code
SESE
Country code
DK
Device name
ICS Dizcovery (1091)
Advisory committee
NE
Contact
Therese Coffey
K number
K242198
Date received
2024-07-26
Review advisory committee
EN
Postal code
DK-2630
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Nystagmograph
Medical specialty description
Neurology
Regulation number
882.1460
Device class
2
Registration number
3034880867, 9710334, 9612197, 3011119387, 3005581270, 3008699634, 3005216736, 3017632068, 2519945, 9710051, 3007532396, 3014133165, 3011522961, 3016159411, 3011310592, 3009391819
FEI number
3034880867, 3002807554, 3011119387, 3005581270, 3008699634, 3005216736, 3017632068, 2519945, 3007532396, 3014133165, 3003244948, 3011522961, 3016159411, 3011310592, 3000254565, 3009391819
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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.