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510(k) K772062

NEONATAL FLOTATION SYSTEM by Medpro, Inc. — Product Code IKY

K772062 is an FDA 510(k) premarket notification submitted by Medpro, Inc. for the device "NEONATAL FLOTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 1977. The device falls under product code IKY (Mattress, Flotation Therapy, Non-Powered), a Class I device regulated under 21 CFR 880.5150. Medpro, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1977
Date Received
November 2, 1977
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 Medpro, Inc.

  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)
  • K760870 — HEEL/ELBOW FLOTATION CUSHION (November 1, 1976)
  • K760613 — FLOTATION UNIT, CHAIR (October 14, 1976)

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)
  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)
  • K760963 — DECUBITUS MATTRESS (November 18, 1976)

FDA data resources