SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565— 510(k) K994353

Name: FDA 510(k) clearance K994353
Creator: U.S. Food and Drug Administration
Published: 2000-03-22

Substantially Equivalent

Precision Dynamics Corp.

FDA 510(k) clearance K994353 for SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565, Substantially Equivalent on 2000-03-22. Applicant: Precision Dynamics Corp.. Device class: 2.

Clearance details

Applicant: Precision Dynamics Corp.
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 1999-12-23
Decision date: 2000-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

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