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Razel Model C

by Razel Scientific Instruments, Inc.

510(k) K811272

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811272 Date10 Jul 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Razel Model C is an infusion pump designed to provide controlled fluid delivery. It functions as a mechanical device intended to regulate the flow of fluids in a clinical or research setting.

This device is supplied by Razel Scientific Instruments, Inc. and is subject to FDA 510(k) regulatory authorization. It is classified under regulation number 880.5725 for general hospital use.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Razel Model C?

    The Razel Model C is a mechanical infusion pump designed to provide controlled fluid delivery. It is intended to regulate the flow of fluids in both clinical and research environments.

  • What is the regulatory status of this device?

    The Razel Model C is subject to FDA 510(k) regulatory authorization. It is classified under regulation number 880.5725 for general hospital use.

  • Who manufactures the Razel Model C?

    This device is manufactured and supplied by Razel Scientific Instruments, Inc., located in Walker, Michigan.