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510(k) K883947

ISO-100 ISOLATION AMPLIFIER by Telediagnostic Systems, Inc. — Product Code GYE

K883947 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "ISO-100 ISOLATION AMPLIFIER". The FDA issued a decision of Substantially Equivalent on December 5, 1988. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Telediagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1988
Date Received
September 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Encephalogram Telemetry System
Device Class
Class II
Regulation Number
882.1855
Review Panel
NE
Submission Type

Other clearances by Telediagnostic Systems, Inc.

  • K071661 — ALPHAONE BIOFEEDBACK SYSTEM (September 5, 2007)
  • K022249 — NIGHTRON POLYSOMNOGRAPHY SYSTEM (December 31, 2002)
  • K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (May 16, 1997)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K904222 — VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER (January 18, 1991)
  • K885328 — RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER (March 22, 1989)
  • K884891 — OC-100 OXIMETER INTERFACE CALIBRATOR (December 28, 1988)
  • K874257 — S-10 TELEPHONIC POLYSOMNOGRAPH (December 11, 1987)
  • K871120 — M10 EEG MONITOR SCOPE (May 1, 1987)
  • K810872 — EEG TELEPHONE RECEIVER MODEL #AFR-J (May 1, 1981)

Other clearances for product code GYE

  • K963195 — WIRELESS EEG RECORDING SYSTEM MODEL W32 (July 29, 1997)
  • K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (May 16, 1997)
  • K895895 — MODEL 219 TELEMETRY SYSTEM (February 22, 1990)
  • K891405 — BMS-2000 MOBILE EEG SYSTEM (August 2, 1989)
  • K885328 — RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER (March 22, 1989)
  • K883461 — DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES (November 30, 1988)
  • K874257 — S-10 TELEPHONIC POLYSOMNOGRAPH (December 11, 1987)
  • K871120 — M10 EEG MONITOR SCOPE (May 1, 1987)
  • K860128 — MODAC-XXXX INTENSIVE MONITORING OF EEG (March 27, 1986)
  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)

FDA data resources