The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Secure-all Fetal Monitor Strap.
| Device ID | K861189 |
| 510k Number | K861189 |
| Device Name: | TECNOL SECURE-ALL FETAL MONITOR STRAP |
| Classification | System, Monitoring, Perinatal |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 7450 WHITEHALL ST. Ft. Worth, TX 76012 |
| Contact | David Archer |
| Correspondent | David Archer TECNOL NEW JERSEY WOUND CARE, INC. 7450 WHITEHALL ST. Ft. Worth, TX 76012 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-04-08 |