SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000— 510(k) K023713

Name: FDA 510(k) clearance K023713
Creator: U.S. Food and Drug Administration
Published: 2004-01-28

Substantially Equivalent

Sontra Medical, Inc.

FDA 510(k) clearance K023713 for SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000, Substantially Equivalent on 2004-01-28. Applicant: Sontra Medical, Inc.. Device class: 2.

Clearance details

Applicant: Sontra Medical, Inc.
Product code: Code KRC
Device class: Class 2
Regulation: 21 CFR 870.2370
Advisory panel: Cardiovascular
Date received: 2002-11-04
Decision date: 2004-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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