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510(k) K863890

MAMM-AIRE by Ar Custom Medical Products, Ltd. — Product Code KXH

K863890 is an FDA 510(k) premarket notification submitted by Ar Custom Medical Products, Ltd. for the device "MAMM-AIRE". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code KXH (Cradle, Patient, Radiologic), a Class I device regulated under 21 CFR 892.1830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
October 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cradle, Patient, Radiologic
Device Class
Class I
Regulation Number
892.1830
Review Panel
RA
Submission Type

Other clearances for product code KXH

  • K122174 — PEDIATRIC POSITIONER PAD SET (November 16, 2012)
  • K953246 — OCTOROLL (September 29, 1995)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE (October 7, 1993)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K884292 — STRETCHER TABLE (March 31, 1989)
  • K840463 — DIGITAL CRADLE (February 21, 1984)
  • K813561 — SPECTRUM PEDIATRIC CARDLE TABLE (January 29, 1982)

FDA data resources