Device Classification Name |
automated external defibrillators (non-wearable) |
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---|---|---|---|---|
510(k) Number | K023854 | |||
Device Name | SAMARITAN AED, MODEL SAM-01 | |||
Original Applicant |
|
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Original Contact | william j smirles | |||
Regulation Number | 870.5310 | |||
Classification Product Code |
|
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Date Received | 11/19/2002 | |||
Decision Date | 02/14/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Cardiovascular |
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510k Review Panel |
Cardiovascular |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |