The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Pedipadz Reduced Energy Electrode.
Device ID | K072430 |
510k Number | K072430 |
Device Name: | ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Contact | Sean Reynolds |
Correspondent | Sean Reynolds ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-29 |
Decision Date | 2007-11-06 |
Summary: | summary |