The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll E Series 12sl, Analysis Option.
| Device ID | K080232 |
| 510k Number | K080232 |
| Device Name: | ZOLL E SERIES 12SL, ANALYSIS OPTION |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Eileen M Boyle |
| Correspondent | Eileen M Boyle ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-30 |
| Decision Date | 2008-04-23 |
| Summary: | summary |