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510(k) K970659

DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER by Telediagnostic Systems, Inc. — Product Code GYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1997
Date Received
February 21, 1997
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.

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  • 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)
  • K883947 — ISO-100 ISOLATION AMPLIFIER (December 5, 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)
  • 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)
  • K883947 — ISO-100 ISOLATION AMPLIFIER (December 5, 1988)
  • 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)