SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565

Monitor, Uterine Contraction, External (for Use In Clinic)

PRECISION DYNAMICS CORP.

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.

Pre-market Notification Details

Device IDK994353
510k NumberK994353
Device Name:SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
ClassificationMonitor, Uterine Contraction, External (for Use In Clinic)
Applicant PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando,  CA  91340 -3490
ContactKalyna Snylyk
CorrespondentKalyna Snylyk
PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando,  CA  91340 -3490
Product CodeHFM  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-23
Decision Date2000-03-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.