The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Onestep Pediatric Mfe's.
| Device ID | K110978 |
| 510k Number | K110978 |
| Device Name: | ONESTEP PEDIATRIC MFE'S |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL MEDICAL CORPORATION 525 NARRAGANSETT PARK DRIVE Pawtucket, RI 02861 |
| Contact | Robert Morse |
| Correspondent | Robert Morse ZOLL MEDICAL CORPORATION 525 NARRAGANSETT PARK DRIVE Pawtucket, RI 02861 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-07 |
| Decision Date | 2011-05-13 |
| Summary: | summary |