The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Pulse Oximetry Option.
Device ID | K892120 |
510k Number | K892120 |
Device Name: | ESCORT PULSE OXIMETRY OPTION |
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 | 1989-03-31 |
Decision Date | 1989-09-26 |