Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K182958
Device Classification Name
Coil, Magnetic Resonance, Specialty
More FDA Info for this Device
510(K) Number
K182958
Device Name
Coil, Magnetic Resonance, Specialty
Applicant
NeoCoil, LLC
N27 W23910 A Paul Rd.
Pewaukee, WI 53072 US
Other 510(k) Applications for this Company
Contact
Katie Gonzalez
Other 510(k) Applications for this Contact
Regulation Number
892.1000
More FDA Info for this Regulation Number
Classification Product Code
MOS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2018
Decision Date
11/16/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact