The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Fetal Scalp Spiral Electrode.
| Device ID | K911657 |
| 510k Number | K911657 |
| Device Name: | FETAL SCALP SPIRAL ELECTRODE |
| Classification | Electrode, Circular (spiral), Scalp And Applicator |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Michael V Solomita |
| Correspondent | Michael V Solomita ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | HGP |
| CFR Regulation Number | 884.2675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-07-11 |