The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Fetal Spiral Electrode, Model Fse07000.
| Device ID | K030691 |
| 510k Number | K030691 |
| Device Name: | FETAL SPIRAL ELECTRODE, MODEL FSE07000 |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | CLINICAL INNOVATIONS, INC. 747 WEST 4170 SOUTH Murray, UT 84123 |
| Contact | William Dean Wallace |
| Correspondent | William Dean Wallace CLINICAL INNOVATIONS, INC. 747 WEST 4170 SOUTH Murray, UT 84123 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-05 |
| Decision Date | 2003-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838007475 | K030691 | 000 |
| 00884838007468 | K030691 | 000 |
| 00884838007451 | K030691 | 000 |
| 20884838007431 | K030691 | 000 |