The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Fetalflex Fetal Electrode.
| Device ID | K871079 |
| 510k Number | K871079 |
| Device Name: | FETALFLEX FETAL ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 26602 CORPORATE AVE. Hayward, CA 94545 |
| Contact | Paul Ulbrich |
| Correspondent | Paul Ulbrich EPCOM MEDICAL SYSTEMS, INC. 26602 CORPORATE AVE. Hayward, CA 94545 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-07-13 |