510(k) clearances

Ampa One System (AMPA-001)

Neuromodulatory Devices & Applications · Neurology

K243319Substantially EquivalentTraditionalOBP
Open FDA's page for this record
Third party flag
N
City
San Diego
Advisory committee description
Neurology
Address 1
501 W. Broadway
Address 2
Suite 1025
Statement or summary
Summary
Product code
OBP
Zip code
92101
Applicant
Neuromodulatory Devices & Applications
Decision date
2025-02-13
Decision code
SESE
Country code
US
Device name
Ampa One System (AMPA-001)
Advisory committee
NE
Contact
Don Vaughn
K number
K243319
State
CA
Date received
2024-10-23
Review advisory committee
NE
Postal code
92101
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Transcranial Magnetic Stimulator
Medical specialty description
Neurology
Regulation number
882.5805
Device class
2
Registration number
3012823347, 3003127839, 3010300912, 3008881376, 3005545216, 3014251656, 3039167582, 3018708317, 3031980484, 3049392690, 8021774, 3005205657, 3020848550, 3012352782, 3035374386, 3006418479, 3014680784, 3007147067, 9612389, 3004824012, 3005268307, 3003144120, 3017496797, 3029767018, 3029464335, 3019055598, 3045753434
FEI number
3012823347, 3003127839, 3010300912, 3008881376, 3005545216, 3014251656, 3039167582, 3018708317, 3031980484, 3049392690, 1825560, 3005205657, 3020848550, 3012352782, 3035374386, 3002808356, 3004099094, 3006418479, 3007147067, 3004824012, 3005268307, 3003255845, 3017496797, 3029767018, 3029464335, 3019055598, 3045753434
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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.