Device Classification Name |
automated external defibrillators (non-wearable) |
||||
---|---|---|---|---|---|
510(k) Number | K033275 | ||||
Device Name | LIFEPAK 12, 20, 500, CR PLUS | ||||
Applicant |
|
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Applicant Contact | michelle ackermann | ||||
Correspondent |
|
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Correspodent Contact | michelle ackermann | ||||
Regulation Number | 870.5310 | ||||
Classification Product Code |
|
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Date Received | 10/10/2003 | ||||
Decision Date | 11/06/2003 | ||||
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 | Special | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |
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Recalls | CDRH Recalls |