The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Zoll D-900 Defibrillator.
| Device ID | K913484 |
| 510k Number | K913484 |
| Device Name: | ZOLL D-900 DEFIBRILLATOR |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Rod Boucher |
| Correspondent | Rod Boucher ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-06 |
| Decision Date | 1991-12-16 |