SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE— 510(k) K133144

Name: FDA 510(k) clearance K133144
Creator: U.S. Food and Drug Administration
Published: 2014-03-19

Substantially Equivalent

Crossbay Medical, Inc.

FDA 510(k) clearance K133144 for SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE, Substantially Equivalent on 2014-03-19. Applicant: Crossbay Medical, Inc.. Device class: 2.

Clearance details

Applicant: Crossbay Medical, Inc.
Product code: Code PGK
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2013-10-17
Decision date: 2014-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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