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Humi-Flow (6-850-00 +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010053

by Northgate Technologies Inc.

Identifiers

510(k) Number: K010053 FDA 510(k)
FDA Product Code: HIF FDA 510(k)
Models / Variants: 6-850-00 FDA 510(k)
01 FDA 510(k)
02 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.1730 FDA 510(k)
Regulation Number: 884.1730 FDA 510(k)
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Humi-Flow (6-850-00 +2 more) by Northgate Technologies Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Northgate Technologies Inc.
FDA Applicant: Northgate Technologies, Inc.

Sources (1)

FDA 510(k) K010053 24 fields · synced Jun 18, 2026