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510(k) K863890

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

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

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  • 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)