Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K142803 |
Device Name |
Skintact, various other tradenames |
Applicant |
Leonhard Lang GmbH |
Archenweg 56 |
Innsbruck,
AT
6020
|
|
Applicant Contact |
Burrhus Lang |
Correspondent |
Paladin Medical, Inc. |
P.O. Box 560 |
Stillwater,
MN
55082
|
|
Correspondent Contact |
Elaine Duncan |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/29/2014 |
Decision Date | 12/02/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|