The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll D 5400 Adult Solid Gel Defibrillation Electro.
| Device ID | K931804 |
| 510k Number | K931804 |
| Device Name: | ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| 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 | LDD |
| Subsequent Product Code | DRK |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DRX |
| Subsequent Product Code | MKJ |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-12 |
| Decision Date | 1993-10-08 |