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510(k) K832483

MATTRESS COVER, ANTI-MICROBIAL by American Threshold Industries, Inc. — Product Code FMW

K832483 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "MATTRESS COVER, ANTI-MICROBIAL". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. American Threshold Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
July 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type

Other clearances by American Threshold Industries, Inc.

  • K971483 — SECURE-WRAP (TM) STERILIZATION WRAP (June 24, 1997)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K952114 — KOOL GARD SINGLES GOWN (September 25, 1995)
  • K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN (September 25, 1995)
  • K952116 — COVER GOWN (September 5, 1995)
  • K934085 — MODIFICATION OF SURGICAL EYESHIELD MASK (November 12, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K915740 — DISPOSABLE O.R. TOWEL, STERILE (June 22, 1992)
  • K912110 — DISPOSABLE O.R. TOWEL (July 25, 1991)

Other clearances for product code FMW

  • K152884 — DermaTherapy Bed Linens (June 20, 2016)
  • K061242 — DERMATHERAPY, MODEL 22216 (January 25, 2007)
  • K001003 — Z-NET (December 10, 2001)
  • K992702 — EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PI (November 8, 1999)
  • K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MAT (February 25, 1994)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K924807 — REUSABLE INCONTIENT UNDERPAD (February 10, 1993)
  • K924477 — WIPEABLE PILLOW (January 29, 1993)
  • K921928 — SOFT-COVER (November 6, 1992)
  • K923173 — OBALON COVER (November 6, 1992)

FDA data resources