Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K231328
Device Classification Name
Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
More FDA Info for this Device
510(K) Number
K231328
Device Name
Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
Applicant
Boston Scientific Corp
4100 Hamline Ave North
St. Paul, MN 55112 US
Other 510(k) Applications for this Company
Contact
Melissa Klamerus
Other 510(k) Applications for this Contact
Regulation Number
870.1025
More FDA Info for this Regulation Number
Classification Product Code
MXD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/08/2023
Decision Date
08/19/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact