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FDA 510(k)

FlowMet-R

K-Number: K182494 · 2019-02-27

Decision Date2019-02-27
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowMet-R is the device name listed in this FDA 510(k) record. The listed applicant is Laser Associated Sciences, Inc.. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K182494. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowMet-R?

FlowMet-R is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Laser Associated Sciences, Inc.. The 510(k) number is K182494.

When did FlowMet-R receive FDA 510(k) clearance?

FlowMet-R received FDA 510(k) clearance on 2019-02-27, under 510(k) number K182494.

Who is the listed applicant for FlowMet-R?

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

What is the FDA product code for FlowMet-R?

The FDA product code for FlowMet-R is DPW.

Other records listing Laser Associated Sciences, Inc. 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.

Related Devices (Code: DPW)

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.

Official Source

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