The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Stat Padz Sterile Adult Multi-function Electrodes.
| Device ID | K943698 |
| 510k Number | K943698 |
| Device Name: | STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 -4420 |
| Contact | Blake A Cerullo |
| Correspondent | Blake A Cerullo ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 -4420 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-29 |
| Decision Date | 1994-12-28 |