Product code FMW— General Hospital
ALLERGY CONTROL COVERS
- Classification name
- Cover, Mattress (Medical Purposes)
- Device class
- Class 1
- Regulation
- 21 CFR 880.6190
- Advisory panel
- General Hospital
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code FMW
FDA has cleared devices under product code FMW between 1978 and 2016, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2016
- 2007
- 2001
- 1999
- 1994
- 1993
- 1992
- 1990
- 1984
- 1978
Top applicants under product code FMW
Recent clearances under product code FMW
- K152884 — DermaTherapy Bed Linens
- K061242 — DERMATHERAPY, MODEL 22216
- K001003 — Z-NET
- K992702 — EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
- K935220 — CORE PREVENT MATTRESS MODIFICATION
- K924807 — REUSABLE INCONTIENT UNDERPAD
- K924477 — WIPEABLE PILLOW
- K921928 — SOFT-COVER
- K923173 — OBALON COVER
- K903382 — ALLERGY CONTROL COVERS
- K902446 — DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
- K832483 — MATTRESS COVER, ANTI-MICROBIAL
- K780033 — MATTRESSES, CONDUCTIVE & COVERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.