The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Pd-1400 Pacer/defibrillator.
| Device ID | K932028 |
| 510k Number | K932028 |
| Device Name: | PD-1400 PACER/DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Gary Freeman |
| Correspondent | Gary Freeman ZOLL MEDICAL CORP. 500 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-26 |
| Decision Date | 1993-10-08 |