The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Model 300.
Device ID | K902060 |
510k Number | K902060 |
Device Name: | ESCORT MODEL 300 |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-07 |
Decision Date | 1990-06-11 |