M10 EEG MONITOR SCOPE— 510(k) K871120

Name: FDA 510(k) clearance K871120
Creator: U.S. Food and Drug Administration
Published: 1987-05-01

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K871120 for M10 EEG MONITOR SCOPE, Substantially Equivalent on 1987-05-01. Applicant: Telediagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Telediagnostic Systems, Inc.
Product code: Code GYE
Device class: Class 2
Regulation: 21 CFR 882.1855
Advisory panel: Neurology
Date received: 1987-03-19
Decision date: 1987-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYE

view all

K963195 — WIRELESS EEG RECORDING SYSTEM MODEL W321997-07-29
K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER1997-05-16
K895895 — MODEL 219 TELEMETRY SYSTEM1990-02-22
K891405 — BMS-2000 MOBILE EEG SYSTEM1989-08-02
K885328 — RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER1989-03-22

More clearances from Telediagnostic Systems, Inc.

view all

K071661 — ALPHAONE BIOFEEDBACK SYSTEM2007-09-05
K022249 — NIGHTRON POLYSOMNOGRAPHY SYSTEM2002-12-31
K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM1991-06-18
K904222 — VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER1991-01-18
K884891 — OC-100 OXIMETER INTERFACE CALIBRATOR1988-12-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.