SMART KLAMP VARIOUS BY SIZE— 510(k) K032091

Name: FDA 510(k) clearance K032091
Creator: U.S. Food and Drug Administration
Published: 2004-03-08

Substantially Equivalent

Emergogroup, Inc.

FDA 510(k) clearance K032091 for SMART KLAMP VARIOUS BY SIZE, Substantially Equivalent on 2004-03-08. Applicant: Emergogroup, Inc.. Device class: 2.

Clearance details

Applicant: Emergogroup, Inc.
Product code: Code HFX
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2003-07-07
Decision date: 2004-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HFX

product code HFX

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.