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510(k) K943837

CHIN UP by Edward Carden — Product Code CCX

K943837 is an FDA 510(k) premarket notification submitted by Edward Carden for the device "CHIN UP". The FDA issued a decision of Substantially Equivalent on October 14, 1994. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
August 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Patient Position
Device Class
Class I
Regulation Number
868.6820
Review Panel
AN
Submission Type

Other clearances for product code CCX

  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K934235 — SNIFF POSITION PILLOW (October 1, 1993)
  • K861915 — SURGICAL HEAD SUPPORT (May 30, 1986)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K821838 — VARI-SUPPORT LOW BACK POSTURE PILLOW (July 20, 1982)
  • K810035 — PRENATAL SUPPORT PILLOW (January 23, 1981)
  • K801330 — ANSPACH LEG SUPPORT (June 26, 1980)

FDA data resources