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510(k) K833022

AIR UTERINE DISPLACER-AUD 120 by Scientific Sales Intl., Inc. — Product Code CCX

K833022 is an FDA 510(k) premarket notification submitted by Scientific Sales Intl., Inc. for the device "AIR UTERINE DISPLACER-AUD 120". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820. Scientific Sales Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
September 6, 1983
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 by Scientific Sales Intl., Inc.

  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K940799 — FLEXGUIDE (August 18, 1994)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K853284 — MYREADER 7 (October 4, 1985)
  • K853285 — MYWASHER 5 (October 4, 1985)
  • K853380 — SPR 2 AUTODILUTER (September 12, 1985)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K802416 — SALEM/RESCE INTUBATION GUIDE (October 23, 1980)

Other clearances for product code CCX

  • K943837 — CHIN UP (October 14, 1994)
  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K934235 — SNIFF POSITION PILLOW (October 1, 1993)
  • K861915 — SURGICAL HEAD SUPPORT (May 30, 1986)
  • 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