The following data is part of a premarket notification filed by Ventrex, Inc. with the FDA for Featherlite Aqua Tocodynamometer.
| Device ID | K061044 |
| 510k Number | K061044 |
| Device Name: | FEATHERLITE AQUA TOCODYNAMOMETER |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | VENTREX, INC. 3007 BUNSEN AVE. SUITE K Ventura, CA 93003 |
| Contact | George Austria |
| Correspondent | George Austria VENTREX, INC. 3007 BUNSEN AVE. SUITE 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 | 2006-04-14 |
| Decision Date | 2006-07-12 |
| Summary: | summary |