Echo-Pulse KM555

FDA 510(k) K821736 · Rabar, Inc.

Substantially Equivalent

510(k) numberK821736

Submission

Device name
Echo-Pulse KM555
Applicant
Rabar, Inc.
Rochester, NY, US
Received
June 14, 1982
Decision date
December 9, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GXW – Echoencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1240
Specialty
Neurology

Other 510(k)s with product code GXW

510(k)DeviceApplicantDecision
K921863Sonos 500, 1000, 1500/SONOS or Ultrasound Imag SysGXW · Traditional Hewlett-Packard Co.09/28/1992SE
K903085SMS-712NAGXW · Traditional Toshiba America Medical Systems, In.C10/05/1990SE
K8534325.0 Iop & 7.5 Iop ProbesGXW · Traditional Diasonics, Inc.02/07/1986SE
K833522Neuro Sector Fixation DeviceGXW · Traditional Advanced Technology Laboratories, Inc.05/25/1984SE
K770788Echoencephalograph, DIGITAL,DIGIECHO2000GXW · Traditional Storz Instrument Co.05/06/1977SE
K770575Echoencephalograph, Digital, 1000GXW · Traditional Storz Instrument Co.04/26/1977SE

More from Storz Instrument Co.

510(k)DeviceDecision
K844017Microtens 7757 T.E.N.S. StimulatorGFJ · Traditional 11/30/1984SE
K842414Echo Pulse BurstGZJ · Traditional 07/27/1984SE

Questions and answers

When was Echo-Pulse KM555 cleared by the FDA?

Echo-Pulse KM555 (K821736) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 178 days after the submission was received.

What is the product code of K821736?

The FDA product code is GXW – Echoencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1240.