510(k) clearances

Background Pattern Classification [BPc(TM)]

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology

K152301Substantially EquivalentTraditionalOMA
Open FDA's page for this record
Third party flag
N
City
Oakville
Advisory committee description
Neurology
Address 1
2568 Bristol Cir.
Statement or summary
Summary
Product code
OMA
Zip code
L6H 5S1
Applicant
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision date
2016-06-03
Decision code
SESE
Country code
CA
Device name
Background Pattern Classification [BPc(TM)]
Advisory committee
NE
Contact
Sanjay Mehta
K number
K152301
Date received
2015-08-14
Review advisory committee
NE
Postal code
L6H 5S1
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Amplitude-Integrated Electroencephalograph
Medical specialty description
Neurology
Regulation number
882.1400
Device class
2
Registration number
3005581270, 9611252, 3015929663, 3013501110, 2031720, 8030229, 9612389, 3016852448, 3023164, 3010611950, 3017374042, 9612330, 2080783
FEI number
3005581270, 3002809369, 3002807720, 3003255845, 3015929663, 3002624053, 3013501110, 3016852448, 3023164, 3010611950, 3017374042, 3002807739, 2080783
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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.