FDA 510(k)

Apogee

K-Number: K200401 · 2020-11-14

Decision Date2020-11-14

Product CodeNFB

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Apogee is the device name listed in this FDA 510(k) record. The listed applicant is Incoba Ltd D/B/A Dynaris. It received FDA 510(k) clearance on 2020-11-14 under 510(k) number K200401. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apogee?

Apogee is a medical device that received FDA 510(k) clearance on 2020-11-14. The listed applicant is Incoba Ltd D/B/A Dynaris. The 510(k) number is K200401.

When did Apogee receive FDA 510(k) clearance?

Apogee received FDA 510(k) clearance on 2020-11-14, under 510(k) number K200401.

Who is the listed applicant for Apogee?

The FDA 510(k) record lists Incoba Ltd D/B/A Dynaris as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apogee?

The FDA product code for Apogee is NFB.

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory K220591ProximaDynasthetics, LLC K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.