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510(k) K760963

DECUBITUS MATTRESS by Arco Medical Products Co. — Product Code IKY

K760963 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "DECUBITUS MATTRESS". The FDA issued a decision of Substantially Equivalent on November 18, 1976. The device falls under product code IKY (Mattress, Flotation Therapy, Non-Powered), a Class I device regulated under 21 CFR 880.5150. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1976
Date Received
November 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Flotation Therapy, Non-Powered
Device Class
Class I
Regulation Number
880.5150
Review Panel
HO
Submission Type

Other clearances by Arco Medical Products Co.

  • K802588 — MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (November 19, 1980)
  • K801806 — EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (September 9, 1980)
  • K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (June 30, 1980)
  • K801241 — UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (June 30, 1980)
  • K800838 — ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. (June 4, 1980)
  • K800326 — ARCOLITH 3021-CARDIAC PULSE GENERATOR (March 17, 1980)
  • K792216 — ARCOLITH 2100-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K792299 — ARCOLITH 3020-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K791715 — ARCOLITH 2000 (September 27, 1979)
  • K791147 — ARCO PROGAMMABLE PACEMAKER SYSTEM (August 3, 1979)

Other clearances for product code IKY

  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K813226 — GEL FLOTATION MATTRESS (December 2, 1981)
  • K802781 — BEDDING PADS EGGCREATE PADS (December 10, 1980)
  • K802833 — TETRA NATAL-MAT WATER FLOTATION MAT. (December 10, 1980)
  • K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS (May 19, 1978)
  • K772062 — NEONATAL FLOTATION SYSTEM (November 15, 1977)
  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)

FDA data resources