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FDA 510(k)

Propeller System

K-Number: K152882 · 2016-03-08

ApplicantReciprocal Labs
Decision Date2016-03-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Propeller System is a medical device manufactured by Reciprocal Labs. It received FDA 510(k) clearance on 2016-03-08 under approval number K152882. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Propeller System?

Propeller System is a medical device that received FDA 510(k) clearance on 2016-03-08. It is manufactured by Reciprocal Labs. The 510(k) number is K152882.

When was Propeller System approved by the FDA?

Propeller System received FDA 510(k) clearance on 2016-03-08, under approval number K152882.

What company makes Propeller System?

Propeller System is manufactured by Reciprocal Labs.

What is the FDA product code for Propeller System?

The FDA product code for Propeller System is CAF.

Other Devices by Reciprocal Labs

K152482Propeller Sensor Model 2014-R

Related Devices (Code: CAF)

K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc. K152482Propeller Sensor Model 2014-RReciprocal Labs K142541POCKET NEBMicrovaper Devices K170916Portable NebulizerMicrobase Technology Corporation K170853InnoSpire GoRespironics Respiratory Drug Delivery (Uk) , Ltd.

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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