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510(k) K885328

RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER by Telediagnostic Systems, Inc. — Product Code GYE

K885328 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER". The FDA issued a decision of Substantially Equivalent on March 22, 1989. 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
March 22, 1989
Date Received
December 28, 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)
  • 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)
  • 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)
  • 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)

FDA data resources