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FDA 510(k)

Ochsner Connected Inhaler Sensor

K-Number: K223367 · 2023-08-30

ApplicantOchsner Clinic Foundation
Decision Date2023-08-30
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ochsner Connected Inhaler Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Ochsner Clinic Foundation. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K223367. 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 Ochsner Connected Inhaler Sensor?

Ochsner Connected Inhaler Sensor is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Ochsner Clinic Foundation. The 510(k) number is K223367.

When did Ochsner Connected Inhaler Sensor receive FDA 510(k) clearance?

Ochsner Connected Inhaler Sensor received FDA 510(k) clearance on 2023-08-30, under 510(k) number K223367.

Who is the listed applicant for Ochsner Connected Inhaler Sensor?

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

What is the FDA product code for Ochsner Connected Inhaler Sensor?

The FDA product code for Ochsner Connected Inhaler Sensor is CAF.

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Official Source

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