The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Ii Clinical Thermometry Module (ctm).
| Device ID | K970011 |
| 510k Number | K970011 |
| Device Name: | ESCORT II CLINICAL THERMOMETRY MODULE (CTM) |
| Classification | Thermometer, Electronic, Clinical |
| 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 | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-07-09 |
| Summary: | summary |