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FDA 510(k)

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

K-Number: K113542 · 2012-02-10

ApplicantSalter Labs, Arvin Facility
Decision Date2012-02-10
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs, Arvin Facility. It received FDA 510(k) clearance on 2012-02-10 under 510(k) number K113542. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)?

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Salter Labs, Arvin Facility. The 510(k) number is K113542.

When did SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) receive FDA 510(k) clearance?

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) received FDA 510(k) clearance on 2012-02-10, under 510(k) number K113542.

Who is the listed applicant for SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)?

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

What is the FDA product code for SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)?

The FDA product code for SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) is BTT.

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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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