The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Statpadz Radiolucent Adult Multi-fuction Electrodes Model 8900-4004.
| Device ID | K960676 |
| 510k Number | K960676 |
| Device Name: | ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Contact | Blake A Cerullo |
| Correspondent | Blake A Cerullo ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-20 |
| Decision Date | 1996-06-05 |