The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll M Series With Rectilinear Bi-phasic Option (m Series Bi-phasic).
| Device ID | K032439 |
| 510k Number | K032439 |
| Device Name: | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Scott August |
| Correspondent | Scott August ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-07 |
| Decision Date | 2003-11-05 |