Fitex

FDA 510(k) K840036 · Britt Corp., Inc.

Substantially Equivalent

510(k) numberK840036

Submission

Device name
Fitex
Applicant
Britt Corp., Inc.
Chanhassen, MN, US
Received
January 5, 1984
Decision date
October 26, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Britt Corp., Inc.

510(k)DeviceDecision
K003828Vaso Press DVT Foot Garment #Vp 520JOW · Traditional 05/18/2001SE
K991038Vaso Press DVT System, Models VP500, VP501JOW · Traditional 06/22/2000SE
K974393Vaso Press SystemJOW · Traditional 03/19/1999SE
K860977Model 545-45 for Neurological Surgical ApplicationLLF · Traditional 10/16/1986SE
K860975Model 545-45 Laser for Ear, Nose & ThroatEWG · Traditional 07/18/1986SE
K860974Model 545-45 Laser for Derma., Pod., SurgicalGEX · Traditional 07/07/1986SE
K860277Model 525-25 Watt C02 Laser for Ear, Nose & ThroatEWG · Traditional 05/06/1986SE
K860273Model 525 - 25 Watt CO2 Medical Laser/PodiatryGEX · Traditional 04/23/1986SE
K860278Model 525-25 Watt CO2 Laser for Derma/PlasticGEX · Traditional 04/15/1986SE
K851425Model J25-25 Watt CO2 LaserHHR · Traditional 11/12/1985SE

Questions and answers

When was Fitex cleared by the FDA?

Fitex (K840036) received a 510(k) decision of Substantially Equivalent on October 26, 1984, 295 days after the submission was received.