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510(k) K926045

SKYTRON LIFE ISLAND 21 by Skytron, Div. the Kmw Group, Inc. — Product Code FNM

K926045 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON LIFE ISLAND 21". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
December 1, 1992
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 by Skytron, Div. the Kmw Group, Inc.

  • K071698 — AURORA LED SERIES SURGICAL LIGHTS (July 6, 2007)
  • K021585 — STELLAR SERIES SURGICAL LIGHTS WITH HERMES (November 13, 2002)
  • K002463 — STELLAR (November 8, 2000)
  • K992090 — MILLENNIUM GOLD (September 8, 1999)
  • K950192 — SKYTRON SKYBOOM SERIES (April 3, 1995)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K915285 — SKYTRON INFINITY SERIES SURGICAL LIGHTS (February 20, 1992)
  • K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (September 4, 1990)
  • K900211 — SKYTRON UNIVERSE SERIES SURGICAL LIGHTS (March 19, 1990)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K974319 — MIGHTY AIR (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