The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Pd2000 Pacemaker/advisory Defibrillator, Model Pd2000, Zoll D2000 Advisory Defibrillator, Model D2000.
| Device ID | K950856 |
| 510k Number | K950856 |
| Device Name: | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Contact | Gary A Freeman |
| Correspondent | Gary A Freeman ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-12-29 |