The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Surepower Single Bay Charger.
| Device ID | K122839 |
| 510k Number | K122839 |
| Device Name: | ZOLL SUREPOWER SINGLE BAY CHARGER |
| Classification | Automated External Defibrillators (non-wearable) |
| 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 | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-17 |
| Decision Date | 2012-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946098957 | K122839 | 000 |
| 00847946022181 | K122839 | 000 |