The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Soft Beat Fetal Heart Rate Electrode Model Sbt-7000.
| Device ID | K003458 |
| 510k Number | K003458 |
| Device Name: | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Contact | Dean Wallace |
| Correspondent | Dean Wallace CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2001-05-03 |