The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Intran Plus.
| Device ID | K905563 |
| 510k Number | K905563 |
| Device Name: | INTRAN PLUS |
| Classification | Monitor, Pressure, Intrauterine |
| 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 | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-12 |
| Decision Date | 1991-06-19 |