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510(k) K926403

PRO-2000 LOW AIR LOSS THERAPY BED by Ch Administration, Inc. — Product Code FNM

K926403 is an FDA 510(k) premarket notification submitted by Ch Administration, Inc. for the device "PRO-2000 LOW AIR LOSS THERAPY BED". The FDA issued a decision of Substantially Equivalent on July 30, 1993. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Ch Administration, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1993
Date Received
December 21, 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 Ch Administration, Inc.

  • K953196 — CARDIO-SYSTEMS PRO-OP (November 8, 1995)
  • K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED (March 24, 1993)

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