Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993788
Device Classification Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
More FDA Info for this Device
510(K) Number
K993788
Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant
NOVACOR DIV.
203 MAIN ST. PMB 166
FLEMINGTON, NJ 08822 US
Other 510(k) Applications for this Company
Contact
LYNETTE L HOWARD
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/1999
Decision Date
08/04/2000
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