The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Pd 1600 Semi-automatic External Defibrillator.
| Device ID | K942344 |
| 510k Number | K942344 |
| Device Name: | ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Contact | Olga Cherniavsky |
| Correspondent | Olga Cherniavsky ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-16 |
| Decision Date | 1995-03-13 |