DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX— 510(k) K112868

Substantially Equivalent

Dreamgard, Inc.

FDA 510(k) clearance K112868 for DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX, Substantially Equivalent on 2012-01-19. Applicant: Dreamgard, Inc..

Clearance details

Applicant: Dreamgard, Inc.
Product code: Code MQC
Advisory panel: Unknown
Date received: 2011-09-30
Decision date: 2012-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.