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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 the device name listed in this FDA 510(k) record. The listed applicant is Reciprocal Labs. It received FDA 510(k) clearance on 2016-03-08 under 510(k) 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. The listed applicant is Reciprocal Labs. The 510(k) number is K152882.

When did Propeller System receive FDA 510(k) clearance?

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

Who is the listed applicant for Propeller System?

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

What is the FDA product code for Propeller System?

The FDA product code for Propeller System is CAF.

Other records listing Reciprocal Labs 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.

K192724Propeller Sensor for SymbicortK180770Propeller Sensor for NeohalerK161454Propeller Sensor Model 2015-EK152482Propeller Sensor Model 2014-R

Related Devices (Code: CAF)

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.

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Official Source

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