The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll E Series Als.
| Device ID | K140502 |
| 510k Number | K140502 |
| Device Name: | ZOLL E SERIES ALS |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Tanmay B Shukla |
| Correspondent | Tanmay B Shukla ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946023010 | K140502 | 000 |
| 00847946019969 | K140502 | 000 |