The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Life Trace Fetal Spiral Electrode With Maternal Reference.
| Device ID | K943732 |
| 510k Number | K943732 |
| Device Name: | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Contact | John H Barrett |
| Correspondent | John H Barrett GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. 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 | 1994-08-02 |
| Decision Date | 1994-10-20 |