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FDA 510(k)

BMLS16-1

K-Number: K172971 · 2018-07-08

ApplicantBiomedical Life Systems, Inc.
Decision Date2018-07-08
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BMLS16-1 is a medical device manufactured by Biomedical Life Systems, Inc.. It received FDA 510(k) clearance on 2018-07-08 under approval number K172971. 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 BMLS16-1?

BMLS16-1 is a medical device that received FDA 510(k) clearance on 2018-07-08. It is manufactured by Biomedical Life Systems, Inc.. The 510(k) number is K172971.

When was BMLS16-1 approved by the FDA?

BMLS16-1 received FDA 510(k) clearance on 2018-07-08, under approval number K172971.

What company makes BMLS16-1?

BMLS16-1 is manufactured by Biomedical Life Systems, Inc..

What is the FDA product code for BMLS16-1?

The FDA product code for BMLS16-1 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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