The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Multi-prong Fetal Scalp Electrode.
| Device ID | K822584 |
| 510k Number | K822584 |
| Device Name: | MULTI-PRONG FETAL SCALP ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | KONTRON INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-26 |
| Decision Date | 1983-02-24 |