The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll M Series Etc02 Loflo Option.
| Device ID | K042417 |
| 510k Number | K042417 |
| Device Name: | ZOLL M SERIES ETC02 LOFLO OPTION |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Sean Reynolds |
| Correspondent | Sean Reynolds ZOLL MEDICAL CORP. 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 | 2004-09-07 |
| Decision Date | 2004-10-05 |
| Summary: | summary |