Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K980624
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K980624
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
UNIVERSAL MEDICAL, INC.
1608 WALNUT ST.
SIXTH FLOOR
PHILADELPHIA, PA 19103 US
Other 510(k) Applications for this Company
Contact
DOUGLAS M LURIO
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/18/1998
Decision Date
05/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact