Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K173952
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K173952
Device Name
Electrocardiograph
Applicant
VectraCor, Inc.
785 Totowa Rd. Suite 100
Totowa, NJ 07512 US
Other 510(k) Applications for this Company
Contact
Andrew Schreck
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
12/27/2017
Decision Date
08/28/2018
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