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FDA 510(k)

DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX

K-Number: K112868 · 2012-01-19

ApplicantDreamgard, Inc.
Decision Date2012-01-19
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX is the device name listed in this FDA 510(k) record. The listed applicant is Dreamgard, Inc.. It received FDA 510(k) clearance on 2012-01-19 under 510(k) number K112868. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX?

DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX is a medical device that received FDA 510(k) clearance on 2012-01-19. The listed applicant is Dreamgard, Inc.. The 510(k) number is K112868.

When did DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX receive FDA 510(k) clearance?

DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX received FDA 510(k) clearance on 2012-01-19, under 510(k) number K112868.

Who is the listed applicant for DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX?

The FDA 510(k) record lists Dreamgard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX?

The FDA product code for DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX is MQC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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