The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Secureline Disposable Fetal Monitoring Straps #3860 And #3565.
| Device ID | K994353 |
| 510k Number | K994353 |
| Device Name: | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Contact | Kalyna Snylyk |
| Correspondent | Kalyna Snylyk PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-03-22 |