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FDA 510(k)

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004

K-Number: K062664 · 2006-12-06

ApplicantApex Medical Corp.
Decision Date2006-12-06
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2006-12-06 under 510(k) number K062664. 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 HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004?

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 is a medical device that received FDA 510(k) clearance on 2006-12-06. The listed applicant is Apex Medical Corp.. The 510(k) number is K062664.

When did HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 receive FDA 510(k) clearance?

HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 received FDA 510(k) clearance on 2006-12-06, under 510(k) number K062664.

Who is the listed applicant for HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004?

The FDA 510(k) record lists Apex Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004?

The FDA product code for HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 is BTT.

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Other records listing Apex Medical Corp. as applicant

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Related Devices (Code: BTT)

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Official Source

View on FDA Database →

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

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