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 |