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510(k) K944094

TRIADYNE by Kinetic Concepts, Inc. — Product Code FNM

K944094 is an FDA 510(k) premarket notification submitted by Kinetic Concepts, Inc. for the device "TRIADYNE". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Kinetic Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1995
Date Received
August 22, 1994
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 Kinetic Concepts, Inc.

  • K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (May 26, 2005)
  • K041642 — V.A.C. GRANUFOAM SILVER DRESSING (January 25, 2005)
  • K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (October 10, 2003)
  • K022011 — V.A.C. ABDOMINAL DRESSING (February 26, 2003)
  • K021500 — VACUUM ASSISTED CLOSURE (December 20, 2002)
  • K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (December 2, 2002)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K992448 — V.A.C. PLUS (January 18, 2000)
  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K972549 — SIMPULSE (November 18, 1997)

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