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Centercom Control

by Carrom Healthcare, Inc.

510(k) K853270

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 NumberK853270 Date13 Nov 1985ClearedStatusActive

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  • Withdrawn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
FNL
Device Class
Class II
Regulation
21 CFR Part 880.5100
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 Centercom Control is a device classified under product code FNL, which is a general hospital device. It is designed to provide control functionality in a hospital setting.

The device is manufactured by Carrom Healthcare, Inc. and received FDA 510(k) clearance in 1985. It is supplied as a single unit and is not specified as single-use or reusable. No MRI safety information is provided in the data.

Other devices from Carrom Healthcare, Inc.

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 Centercom Control used for in a hospital setting?

    The Centercom Control is designed to provide control functionality in a hospital setting. It is classified under product code FNL as a general hospital device, though specific control applications are not detailed in the available information.

  • Is the Centercom Control a single-use or reusable device?

    The device is supplied as a single unit, but the available data does not specify whether it is intended for single-use or reusable purposes. This information would need to be confirmed with the manufacturer directly.

  • What regulatory approvals does the Centercom Control have?

    The Centercom Control received FDA 510(k) clearance in 1985, with a decision code of SESE indicating it was found to be substantially equivalent to other devices on the market. It is manufactured by Carrom Healthcare, Inc. and classified under product code FNL.

  • What are the specifications of the Centercom Control?

    The device is manufactured by Carrom Healthcare, Inc. with headquarters in St. Louis, MO. It received traditional clearance through the FDA 510(k) process and was reviewed by the HO advisory committee. No specific measurements, materials, or technical specifications are provided in the available data.