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FDA 510(k)

O2-IN-A-BOX, O2-IN-A-BOX

K-Number: K102750 · 2011-02-11

ApplicantGeto2, Inc.
Decision Date2011-02-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O2-IN-A-BOX, O2-IN-A-BOX is the device name listed in this FDA 510(k) record. The listed applicant is Geto2, Inc.. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K102750. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O2-IN-A-BOX, O2-IN-A-BOX?

O2-IN-A-BOX, O2-IN-A-BOX is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Geto2, Inc.. The 510(k) number is K102750.

When did O2-IN-A-BOX, O2-IN-A-BOX receive FDA 510(k) clearance?

O2-IN-A-BOX, O2-IN-A-BOX received FDA 510(k) clearance on 2011-02-11, under 510(k) number K102750.

Who is the listed applicant for O2-IN-A-BOX, O2-IN-A-BOX?

The FDA 510(k) record lists Geto2, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O2-IN-A-BOX, O2-IN-A-BOX?

The FDA product code for O2-IN-A-BOX, O2-IN-A-BOX is CAW.

Related Devices (Code: CAW)

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

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