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Ri 300 Differential Temperature Monitor

by Instrumentation Industries, Inc.

510(k) K822831

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 NumberK822831 Date28 Oct 1982ClearedStatusActive

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Ri 300 Differential Temperature Monitor is a device used for monitoring temperature. It is classified under the product code FLL.

The device is supplied by Instrumentation Industries, Inc. and has been found to be substantially equivalent. It has an FDA 510K authorization, with the k number K822831. The device is used in a general hospital setting.

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Questions

AI-generated answers, 23 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 RI 300 used for?

    The RI 300 is used for monitoring temperature in a general hospital setting, providing accurate temperature readings.

  • Is the RI 300 supplied sterile?

    The device data does not specify if the RI 300 is supplied sterile, it's recommended to check the packaging or manufacturer's instructions.

  • What is the regulatory status of the RI 300?

    The RI 300 has an FDA 510K authorization, with the k number K822831, indicating it has been found substantially equivalent.