The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Rescuenet Epcr Model Rescuenet Epcr.
Device ID | K103473 |
510k Number | K103473 |
Device Name: | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR |
Classification | Display, Cathode-ray Tube, Medical |
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 | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-24 |
Decision Date | 2011-05-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847946021917 | K103473 | 000 |
00847946021900 | K103473 | 000 |