Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DripAssist Plus

K-Number: K172242 · 2018-05-25

Decision Date2018-05-25
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DripAssist Plus is the device name listed in this FDA 510(k) record. The listed applicant is Shift Labs, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172242. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DripAssist Plus?

DripAssist Plus is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Shift Labs, Inc.. The 510(k) number is K172242.

When did DripAssist Plus receive FDA 510(k) clearance?

DripAssist Plus received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172242.

Who is the listed applicant for DripAssist Plus?

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

What is the FDA product code for DripAssist Plus?

The FDA product code for DripAssist Plus is FLN.

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.