The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Epcr Ios.
| Device ID | K131919 |
| 510k Number | K131919 |
| Device Name: | ZOLL EPCR IOS |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Shannon Duhamel |
| Correspondent | Shannon Duhamel ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2013-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946021924 | K131919 | 000 |