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FDA 510(k)

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT

K-Number: K122932 · 2013-12-23

ApplicantFogless International AB
Decision Date2013-12-23
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT is the device name listed in this FDA 510(k) record. The listed applicant is Fogless International AB. It received FDA 510(k) clearance on 2013-12-23 under 510(k) number K122932. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT?

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT is a medical device that received FDA 510(k) clearance on 2013-12-23. The listed applicant is Fogless International AB. The 510(k) number is K122932.

When did SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT receive FDA 510(k) clearance?

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT received FDA 510(k) clearance on 2013-12-23, under 510(k) number K122932.

Who is the listed applicant for SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT?

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

What is the FDA product code for SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT?

The FDA product code for SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT is JOH.

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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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