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 |