Everest & Jenning Series 5000 Modular Bed
510(k) K854832
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854832 | Date4 Feb 1986 | 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- Withdrawn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, 27 Sep 2026
The Everest & Jennings Series 5000 Modular Bed is a medical device. It is classified under product code FNL.
The device is supplied by Carrom Healthcare, Inc. and has FDA 510K authorization. It was cleared on February 4, 1986, with decision code SESE, indicating it is substantially equivalent to a predicate device.
Other devices from Carrom Healthcare, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Everest Series 5000 Modular Bed used for?
The device is a medical bed, but its specific use is not detailed in the provided information, however, it is classified under product code FNL, which may indicate its use in general hospital settings.
Is the Everest Series 5000 Modular Bed supplied sterile?
The provided information does not specify if the device is supplied sterile or not, it only mentions that it has FDA 510K authorization.
What is the regulatory status of the Everest Series 5000 Modular Bed?
The device has FDA 510K authorization, which means it was cleared by the FDA as substantially equivalent to a predicate device.