Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220362
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K220362
Device Name
Electrocardiograph
Applicant
CAF Medical Solutions Inc.
17539 Roberts Road
Hockley, TX 77477 US
Other 510(k) Applications for this Company
Contact
Oscar Arriaga Yamin
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2022
Decision Date
03/25/2022
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