The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll R Series.
| Device ID | K081574 |
| 510k Number | K081574 |
| Device Name: | ZOLL R SERIES |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 |
| Contact | Eileen M Boyle |
| Correspondent | Eileen M Boyle ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-05 |
| Decision Date | 2008-09-18 |
| Summary: | summary |