The following data is part of a premarket notification filed by Life Support, Inc. with the FDA for Fe-3000 Fetal Electrode, Spiral System.
| Device ID | K801984 |
| 510k Number | K801984 |
| Device Name: | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | LIFE SUPPORT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-09-09 |