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FDA 510(k)

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

K-Number: K033614 · 2004-07-29

ApplicantNorthgate Technologies, Inc.
Decision Date2004-07-29
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 2004-07-29 under 510(k) number K033614. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215?

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 is a medical device that received FDA 510(k) clearance on 2004-07-29. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K033614.

When did MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 receive FDA 510(k) clearance?

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 received FDA 510(k) clearance on 2004-07-29, under 510(k) number K033614.

Who is the listed applicant for MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215?

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

What is the FDA product code for MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215?

The FDA product code for MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 is HIF.

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Related Devices (Code: HIF)

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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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