The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Intran 500.
| Device ID | K961424 |
| 510k Number | K961424 |
| Device Name: | INTRAN 500 |
| Classification | Transducer, Pressure, Intrauterine |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Kevin L Cornwell |
| Correspondent | Kevin L Cornwell UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | HFN |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-07-10 |
| Summary: | summary |