Ethylene Oxide Steriliz. Parametric Rel.

FDA 510(k) K822240 · American Mcgaw

Substantially Equivalent

510(k) numberK822240

Submission

Device name
Ethylene Oxide Steriliz. Parametric Rel.
Applicant
American Mcgaw
Santa Ana, CA, US
Received
July 27, 1982
Decision date
December 30, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3500
Specialty
Physical Medicine

Other 510(k)s with product code KFX

510(k)DeviceApplicantDecision
K932184Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional Vascutech, Inc.07/22/1993SE
K833868Ipos G.L.P. SystemKFX · Traditional Ipos Luneburg11/28/1983SE
K830285Regnell Hydraulic Femoral ProthesisKFX · Traditional Besco Financial Service03/09/1983SE

More from Besco Financial Service

510(k)DeviceDecision
K853549Mcgaw/Drop Watch Flow MonitorFLN · Traditional 11/12/1985SE
K843639Add-A-Vial Solution Transfer DeviceLHI · Traditional 01/14/1985SE
K843954Mixing ContainerKPE · Traditional 11/28/1984SE
K841729Accupro Enteral Feeding PumpFRN · Traditional 06/01/1984SE
K840388Pab IV ContainerKPE · Traditional 03/06/1984SE
K840212Concentrated Platelet Admin. SetFPA · Traditional 03/06/1984SE
K831716Capd - Catheter AdapterFKX · Traditional 06/24/1983SE
K820133Mcgaw Fat Emulsion SetFPA · Traditional 04/06/1982SE
K813092Accupro I.V. Administration SetFPA · Traditional 12/31/1981SE
K810683Capd Catheter AdapterFKX · Traditional 05/08/1981SE

Questions and answers

When was Ethylene Oxide Steriliz. Parametric Rel. cleared by the FDA?

Ethylene Oxide Steriliz. Parametric Rel. (K822240) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 156 days after the submission was received.

What is the product code of K822240?

The FDA product code is KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External, a Class II (moderate risk) device regulated under 21 CFR 890.3500.