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510(k) K914775

TALLEY MICRO SYSTEM/TALLEY RIPPLEBED by Talley Group, Ltd. — Product Code FNM

K914775 is an FDA 510(k) premarket notification submitted by Talley Group, Ltd. for the device "TALLEY MICRO SYSTEM/TALLEY RIPPLEBED". The FDA issued a decision of Substantially Equivalent on April 10, 1992. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Talley Group, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1992
Date Received
October 23, 1991
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 Talley Group, Ltd.

  • K151263 — Venturi Gauze Wound Care Sets with Portal Drain (February 19, 2016)
  • K143004 — VENTURI MiNO TG600/14 (January 5, 2016)
  • K914774 — MULTIPULSE SEQUENTIAL COMPRESSION UNIT (February 11, 1992)
  • K914776 — OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (December 19, 1991)
  • K914780 — TALLEY SD.500 SKIN PRESSURE EVALUATOR (December 19, 1991)

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