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510(k) K992702

EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM by Allergy Direct — Product Code FMW

K992702 is an FDA 510(k) premarket notification submitted by Allergy Direct for the device "EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 1999. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1999
Date Received
August 12, 1999
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

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  • K061242 — DERMATHERAPY, MODEL 22216 (January 25, 2007)
  • K001003 — Z-NET (December 10, 2001)
  • 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)
  • K903382 — ALLERGY CONTROL COVERS (November 2, 1990)

FDA data resources