Neonatal Flotation System

FDA 510(k) K772062 · Medpro, Inc.

Substantially Equivalent

510(k) numberK772062

Submission

Device name
Neonatal Flotation System
Applicant
Medpro, Inc.
Mchenry, IL, US
Received
November 2, 1977
Decision date
November 15, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IKY – Mattress, Flotation Therapy, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 880.5150
Specialty
General Hospital

Other 510(k)s with product code IKY

510(k)DeviceApplicantDecision
K914921SCM-3 and AccessoriesIKY · Traditional Gaymar Industries, Inc.03/12/1992SE
K813226Gel Flotation MattressIKY · Traditional Jefferson Industries, Inc.12/02/1981SE
K802833Tetra Natal-Mat Water Flotation Mat.IKY · Traditional Tetra Group U.S.A., Inc.12/10/1980SE
K802781Bedding Pads Eggcreate PadsIKY · Traditional Leemart Bedding Mfg. Co.12/10/1980SE
K780779Econo-Float Water Flotation MattressIKY · Traditional Jefferson Industries, Inc.05/19/1978SE
K771824Medpro Flotation SystemIKY · Traditional Medpro, Inc.10/19/1977SE
K760963Decubitus MattressIKY · Traditional Arco Medical Products Co.11/18/1976SE

More from Arco Medical Products Co.

510(k)DeviceDecision
K771824Medpro Flotation SystemIKY · Traditional 10/19/1977SE
K760870Heel/Elbow Flotation CushionFMP · Traditional 11/01/1976SE
K760613Flotation Unit, ChairKIC · Traditional 10/14/1976SE

Questions and answers

When was Neonatal Flotation System cleared by the FDA?

Neonatal Flotation System (K772062) received a 510(k) decision of Substantially Equivalent on November 15, 1977, 13 days after the submission was received.

What is the product code of K772062?

The FDA product code is IKY – Mattress, Flotation Therapy, Non-Powered, a Class I (low risk) device regulated under 21 CFR 880.5150.