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510(k) K802833

TETRA NATAL-MAT WATER FLOTATION MAT. by Tetra Group U.S.A., Inc. — Product Code IKY

K802833 is an FDA 510(k) premarket notification submitted by Tetra Group U.S.A., Inc. for the device "TETRA NATAL-MAT WATER FLOTATION MAT.". The FDA issued a decision of Substantially Equivalent on December 10, 1980. The device falls under product code IKY (Mattress, Flotation Therapy, Non-Powered), a Class I device regulated under 21 CFR 880.5150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1980
Date Received
November 12, 1980
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 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)
  • K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS (May 19, 1978)
  • K772062 — NEONATAL FLOTATION SYSTEM (November 15, 1977)
  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)
  • K760963 — DECUBITUS MATTRESS (November 18, 1976)

FDA data resources