The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Rescuenet 12-lead.
| Device ID | K121865 |
| 510k Number | K121865 |
| Device Name: | ZOLL RESCUENET 12-LEAD |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Charles W Kolifrath |
| Correspondent | Charles W Kolifrath ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-26 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946021870 | K121865 | 000 |
| 00847946021863 | K121865 | 000 |