The following data is part of a premarket notification filed by Ventrex, Inc. with the FDA for Toco Lite, Model Td-01.
| Device ID | K013477 |
| 510k Number | K013477 |
| Device Name: | TOCO LITE, MODEL TD-01 |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | VENTREX, INC. 3007 BUNSEN AVE., UNIT L & K Ventura, CA 93003 |
| Contact | Robert Guthrie |
| Correspondent | Robert Guthrie VENTREX, INC. 3007 BUNSEN AVE., UNIT L & K Ventura, CA 93003 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-19 |
| Decision Date | 2002-01-17 |
| Summary: | summary |