The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort 300 Series.
Device ID | K911665 |
510k Number | K911665 |
Device Name: | ESCORT 300 SERIES |
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 | 1991-04-12 |
Decision Date | 1991-08-29 |