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510(k) K930730

DORMIE NECK SUPPORT SYSTEM by The Western Diagnostics Co. — Product Code IQK

K930730 is an FDA 510(k) premarket notification submitted by The Western Diagnostics Co. for the device "DORMIE NECK SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
February 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cervical
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances for product code IQK

  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)
  • K832001 — HEAD-IMMOBILIZER (July 12, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830350 — CERVICAL PILLOW (March 9, 1983)
  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)

FDA data resources