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510(k) K971568

REST MATTRESS by Rest Mattress — Product Code FNM

K971568 is an FDA 510(k) premarket notification submitted by Rest Mattress for the device "REST MATTRESS". The FDA issued a decision of Substantially Equivalent on July 18, 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
July 18, 1997
Date Received
April 29, 1997
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)
  • K965207 — RID-DECUBE II (August 21, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)

FDA data resources