Devetherm

FDA 510(k) K822873 · Eko Scann AB

Substantially Equivalent

510(k) numberK822873

Submission

Device name
Devetherm
Applicant
Eko Scann AB
Mchenry, IL, US
Received
September 27, 1982
Decision date
March 24, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQB – Phlebograph, Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2750
Specialty
Cardiovascular

Other 510(k)s with product code DQB

510(k)DeviceApplicantDecision
K851102Vasoscreen Impedance PlethysmographDQB · Traditional Sonicaid, Inc.05/16/1985SE
K772093Impedance RheographDQB · Traditional Dynatech Research & Development Co.11/18/1977SE

More from Dynatech Research & Development Co.

510(k)DeviceDecision
K822823Hematology Computer-Interface, ViscountLKM · Traditional 10/18/1982SE

Questions and answers

When was Devetherm cleared by the FDA?

Devetherm (K822873) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 178 days after the submission was received.

What is the product code of K822873?

The FDA product code is DQB – Phlebograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2750.