Post Extra Systolic Postentlator

FDA 510(k) K791959 · Medrad, Inc.

Substantially Equivalent

510(k) numberK791959

Submission

Device name
Post Extra Systolic Postentlator
Applicant
Medrad, Inc.
Mchenry, IL, US
Received
October 1, 1979
Decision date
January 9, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXO – Synchronizer, Ecg / Respirator, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1970
Specialty
Radiology

Other 510(k)s with product code IXO

510(k)DeviceApplicantDecision
K854976Rmi Respiratory Gating System Model 301IXO · Traditional Radiation Measurements, Inc.05/07/1986SE
K811587Siemens AngiotronIXO · Traditional Siemens Corp.07/10/1981SE
K810588Synchronizer #208IXO · Traditional Brattle Instrument Corp.04/10/1981SE

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Questions and answers

When was Post Extra Systolic Postentlator cleared by the FDA?

Post Extra Systolic Postentlator (K791959) received a 510(k) decision of Substantially Equivalent on January 9, 1980, 100 days after the submission was received.

What is the product code of K791959?

The FDA product code is IXO – Synchronizer, Ecg / Respirator, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1970.