FDA 510(k)

MedDream

K-Number: K162011 · 2016-10-14

Decision Date2016-10-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MedDream is the device name listed in this FDA 510(k) record. The listed applicant is Softneta Uab. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K162011. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedDream?

MedDream is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Softneta Uab. The 510(k) number is K162011.

When did MedDream receive FDA 510(k) clearance?

MedDream received FDA 510(k) clearance on 2016-10-14, under 510(k) number K162011.

Who is the listed applicant for MedDream?

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

What is the FDA product code for MedDream?

The FDA product code for MedDream is LLZ.

Other records listing Softneta Uab as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222320MedDream

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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.