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510(k) K904328

VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM by Telediagnostic Systems, Inc. — Product Code GWK

K904328 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 18, 1991. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Telediagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1991
Date Received
September 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
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)
  • 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 GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K991045 — MINI-LOGGER SERIES 2000 (September 21, 1999)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)
  • K860914 — ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (June 6, 1986)

FDA data resources