The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Bubble Toco.
| Device ID | K920152 |
| 510k Number | K920152 |
| Device Name: | BUBBLE TOCO |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Edwin O Goodman |
| Correspondent | Edwin O Goodman UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-13 |
| Decision Date | 1993-05-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BUBBLE TOCO 74372854 1849173 Dead/Cancelled |
Utah Medical Products, Inc. 1993-03-29 |