The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort 300a Series Defibrillator/pacer Option.
| Device ID | K914458 |
| 510k Number | K914458 |
| Device Name: | ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | Chip Harlow |
| Correspondent | Chip Harlow MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1991-12-09 |