The following data is part of a premarket notification filed by Sontra Medical Inc. with the FDA for Sonoprep Impedance Diagnostics (idx) System, Model D1000.
| Device ID | K023713 |
| 510k Number | K023713 |
| Device Name: | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 |
| Classification | Tester, Electrode, Surface, Electrocardiographic |
| Applicant | SONTRA MEDICAL INC. 58 CHARLES ST. Cambridge, MA 02141 |
| Contact | Albert Farinha |
| Correspondent | Albert Farinha SONTRA MEDICAL INC. 58 CHARLES ST. Cambridge, MA 02141 |
| Product Code | KRC |
| CFR Regulation Number | 870.2370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-04 |
| Decision Date | 2004-01-28 |
| Summary: | summary |