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510(k) K921928

SOFT-COVER by Adroit Medical Systems, Inc. — Product Code FMW

K921928 is an FDA 510(k) premarket notification submitted by Adroit Medical Systems, Inc. for the device "SOFT-COVER". The FDA issued a decision of Substantially Equivalent on November 6, 1992. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. Adroit Medical Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
April 24, 1992
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 Adroit Medical Systems, Inc.

  • K073712 — SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 (June 6, 2008)
  • K973981 — SAFEPASS STERILIZATION POUCH (January 29, 1998)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K962983 — STERILE SOFT-TEMP (January 10, 1997)
  • K921920 — SOFT-TEMP (December 11, 1992)

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)
  • K923173 — OBALON COVER (November 6, 1992)
  • K903382 — ALLERGY CONTROL COVERS (November 2, 1990)

FDA data resources