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510(k) K926291

SCHUL-TEC IMMOBILIZER by Medical Emergency Support Equipment — Product Code IQK

K926291 is an FDA 510(k) premarket notification submitted by Medical Emergency Support Equipment for the device "SCHUL-TEC IMMOBILIZER". The FDA issued a decision of Substantially Equivalent on March 30, 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
March 30, 1993
Date Received
December 14, 1992
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

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 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)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)
  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)

FDA data resources