The following data is part of a premarket notification filed by Medical Accessories, Inc. with the FDA for Fetal Scalp Electrode.
| Device ID | K872057 |
| 510k Number | K872057 |
| Device Name: | FETAL SCALP ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | MEDICAL ACCESSORIES, INC. 92 YOUNGS RD. Trenton, NJ 08619 |
| Contact | Janis G Ziedonis |
| Correspondent | Janis G Ziedonis MEDICAL ACCESSORIES, INC. 92 YOUNGS RD. Trenton, NJ 08619 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-28 |
| Decision Date | 1987-11-16 |