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510(k) K904222

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER by Telediagnostic Systems, Inc. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1991
Date Received
September 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

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  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 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)

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