← Back to catalogue

Super-Flow Tubing

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922245

by Armm Inc.

Identifiers

510(k) Number
K922245 FDA 510(k)
FDA Product Code
HIF 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)

Super-Flow Tubing by Armm Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Armm Inc.
FDA Applicant
Armm, Inc.

Sources (1)

  • FDA 510(k) K922245 24 fields · synced Jun 18, 2026