Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K090037
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K090037
Device Name
Detector And Alarm, Arrhythmia
Applicant
MEDICALGORITHMICS SP Z.O.O.
245 WEST 107TH STREET
SUITE 11A
NEW YORK, NY 10025 US
Other 510(k) Applications for this Company
Contact
MARTIN JASINSKI
Other 510(k) Applications for this Contact
Regulation Number
870.1025
More FDA Info for this Regulation Number
Classification Product Code
DSI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2009
Decision Date
05/22/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact