The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Portable Patient Monitor.
Device ID | K872291 |
510k Number | K872291 |
Device Name: | ESCORT PORTABLE PATIENT MONITOR |
Classification | Transducer, Pressure, Catheter Tip |
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 | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-16 |
Decision Date | 1987-09-25 |