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FDA 510(k)

Beddr 200 System

K-Number: K190399 · 2019-08-05

ApplicantHancock Medical, Inc.
Decision Date2019-08-05
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Beddr 200 System is the device name listed in this FDA 510(k) record. The listed applicant is Hancock Medical, Inc.. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K190399. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Beddr 200 System?

Beddr 200 System is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Hancock Medical, Inc.. The 510(k) number is K190399.

When did Beddr 200 System receive FDA 510(k) clearance?

Beddr 200 System received FDA 510(k) clearance on 2019-08-05, under 510(k) number K190399.

Who is the listed applicant for Beddr 200 System?

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

What is the FDA product code for Beddr 200 System?

The FDA product code for Beddr 200 System is DQA.

Related Devices (Code: DQA)

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.

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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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