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510(k) K911057

DERMATEK 4000 by Anacom General Corp. — Product Code INX

K911057 is an FDA 510(k) premarket notification submitted by Anacom General Corp. for the device "DERMATEK 4000". The FDA issued a decision of Substantially Equivalent on April 5, 1991. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1991
Date Received
March 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

Other clearances for product code INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K964223 — CLINITRON RITE-HITE (May 28, 1997)
  • K943385 — CLINITRON ELEXIS (February 27, 1995)
  • K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY (February 7, 1995)
  • K931168 — X-20 AIR SUPPORT BED (February 17, 1994)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K924973 — DYLNAMEDICS A.S.A.P. (October 15, 1993)
  • K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED (March 24, 1993)
  • K924686 — REM-AIR (February 12, 1993)
  • K920112 — CLINITRON C-II (January 24, 1992)

FDA data resources