Atlas FDA

PADPRO, MODEL 2603

FDA 510(k) clearance K020288 · decided 2002-02-27

Clearance details

K-number
K020288
Device name
PADPRO, MODEL 2603
Applicant
Padpro, LLC
Decision
Substantially Equivalent
Date received
2002-01-28
Decision date
2002-02-27
Days to decision
30 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Deer Field, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO recall (Z-0459-2015)ConMed Corporation2014-12-04