Spectrum Analyzer 8000

FDA 510(k) K810851 · Radionics Medical, Inc.

Substantially Equivalent

510(k) numberK810851

Submission

Device name
Spectrum Analyzer 8000
Applicant
Radionics Medical, Inc.
Mchenry, IL, US
Received
March 30, 1981
Decision date
April 23, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1435
Specialty
Cardiovascular

Other 510(k)s with product code DXG

510(k)DeviceApplicantDecision
K253092Argos Infinity (Rev. 1.0)DXG · Traditional Retia Medical Systems, Inc.02/13/2026SE
K251275VitalStream ART Connect; VitalStream-HemoDXG · Traditional Caretaker Medical09/26/2025SE
K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSDXG · Traditional Icu Medical12/20/2023SE
K212529Hypotension Decision Assist Model HDA-OR2DXG · Special Directed Systems, Ltd.11/23/2021SE
K192169PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional Pulsion Medical Systems SE04/30/2020SE
K193179EV1000 Clinical PlatformDXG · Special Edwards Lifesciences, LLC12/17/2019SE
K190955Hypotension Decision AssistDXG · Traditional Directed Systems, Ltd.11/27/2019SE
K181372ArgosDXG · Traditional Retia Medical, LLC12/13/2018SE
K172259PulsioFlex Monitoring SystemDXG · Traditional Pulsion Medical Systems SE01/18/2018SE
K163334LiDCOunity v2 Hemodynamic MonitorDXG · Traditional Lidco, Ltd.06/05/2017SE

More from Lidco, Ltd.

510(k)DeviceDecision
K844299Corneomap 4500IYO · Traditional 04/18/1985SE
K833222Sinusvu 2500IYO · Traditional 11/28/1983SE
K837331Corneomap 4500 Ultrasound Measurement · Traditional 05/09/1983SE
K827035Ocular Biometer 4000 · Traditional 07/22/1982SE

Questions and answers

When was Spectrum Analyzer 8000 cleared by the FDA?

Spectrum Analyzer 8000 (K810851) received a 510(k) decision of Substantially Equivalent on April 23, 1981, 24 days after the submission was received.

What is the product code of K810851?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.