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 |