The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Zoll Pd 2200 Pacing-defibrillation Electrodes.
| Device ID | K895032 |
| 510k Number | K895032 |
| Device Name: | ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ZMI CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Paul A Levesque |
| Correspondent | Paul A Levesque 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 | 1989-08-08 |
| Decision Date | 1989-10-12 |