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510(k) K934235

SNIFF POSITION PILLOW by American Medical Development, Inc. — Product Code CCX

K934235 is an FDA 510(k) premarket notification submitted by American Medical Development, Inc. for the device "SNIFF POSITION PILLOW". The FDA issued a decision of Substantially Equivalent on October 1, 1993. 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 1, 1993
Date Received
August 30, 1993
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

  • K943837 — CHIN UP (October 14, 1994)
  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 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