The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll X Series.
| Device ID | K133484 |
| 510k Number | K133484 |
| Device Name: | ZOLL X SERIES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Tanmay Shukla |
| Correspondent | Tanmay Shukla ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | LDD |
| Subsequent Product Code | LIX |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2014-08-01 |
| Summary: | summary |