K994353 is an FDA 510(k) clearance for the SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565. This device is classified as a Monitor, Uterine Contraction, External (for Use In Clinic) (Class II - Special Controls, product code HFM).
Submitted by Precision Dynamics Corp. (San Fernando, US). The FDA issued a Cleared decision on March 22, 2000, 90 days after receiving the submission on December 23, 1999.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2720.
| 510(k) Number | K994353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1999 |
| Decision Date | March 22, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFM — Monitor, Uterine Contraction, External (for Use In Clinic) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2720 |