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510(k) K965207

RID-DECUBE II by Skin Care Management, Inc. — Product Code FNM

K965207 is an FDA 510(k) premarket notification submitted by Skin Care Management, Inc. for the device "RID-DECUBE II". The FDA issued a decision of Substantially Equivalent on August 21, 1997. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1997
Date Received
December 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K974319 — MIGHTY AIR (January 22, 1998)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K974070 — PHYSIO/1000 (January 6, 1998)
  • K972549 — SIMPULSE (November 18, 1997)
  • K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (November 7, 1997)
  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)
  • K954320 — MODIFIED PEDIKAIR (July 18, 1997)

FDA data resources