MAMM-AIRE— 510(k) K863890

Substantially Equivalent

Ar Custom Medical Products, Ltd.

FDA 510(k) clearance K863890 for MAMM-AIRE, Substantially Equivalent on 1986-10-14. Applicant: Ar Custom Medical Products, Ltd.. Device class: 1.

Clearance details

Applicant: Ar Custom Medical Products, Ltd.
Product code: Code KXH
Device class: Class 1
Regulation: 21 CFR 892.1830
Advisory panel: Radiology
Date received: 1986-10-06
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Park, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXH

K122174 — PEDIATRIC POSITIONER PAD SET2012-11-16
K953246 — OCTOROLL1995-09-29
K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE1994-02-09
K933134 — SPECTRUM DG-P7000 PEDIATRIC CRADLE1993-10-07
K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE1993-07-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.