The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Modular Telemetry System (mts) Option For The Mde Escort Ii Monitor.
| Device ID | K970763 |
| 510k Number | K970763 |
| Device Name: | MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR |
| Classification | Oximeter |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | David M Trueblood |
| Correspondent | David M Trueblood 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 | 1997-03-03 |
| Decision Date | 1997-07-14 |
| Summary: | summary |