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FDA 510(k)

CUR Model 1

K-Number: K160052 · 2016-05-20

ApplicantThimble Bioelectronics, Inc.
Decision Date2016-05-20
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CUR Model 1 is a medical device manufactured by Thimble Bioelectronics, Inc.. It received FDA 510(k) clearance on 2016-05-20 under approval number K160052. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUR Model 1?

CUR Model 1 is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Thimble Bioelectronics, Inc.. The 510(k) number is K160052.

When was CUR Model 1 approved by the FDA?

CUR Model 1 received FDA 510(k) clearance on 2016-05-20, under approval number K160052.

What company makes CUR Model 1?

CUR Model 1 is manufactured by Thimble Bioelectronics, Inc..

What is the FDA product code for CUR Model 1?

The FDA product code for CUR Model 1 is NUH.

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Official Source

View on FDA Database →

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

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