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510(k) K963195

WIRELESS EEG RECORDING SYSTEM MODEL W32 by Cme Telemetrix, Inc. — Product Code GYE

K963195 is an FDA 510(k) premarket notification submitted by Cme Telemetrix, Inc. for the device "WIRELESS EEG RECORDING SYSTEM MODEL W32". The FDA issued a decision of Substantially Equivalent on July 29, 1997. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1997
Date Received
August 15, 1996
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 for product code GYE

  • 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)
  • 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