Centercom Control
510(k) K853270
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853270 | Date13 Nov 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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
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.