The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Fetal Monitoring Spiral Electrode.
| Device ID | K905130 |
| 510k Number | K905130 |
| Device Name: | FETAL MONITORING SPIRAL ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Van Dine |
| Correspondent | Van Dine GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-15 |
| Decision Date | 1991-01-29 |