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510(k) K860128

MODAC-XXXX INTENSIVE MONITORING OF EEG by Grass-Telefactor Product Group — Product Code GYE

K860128 is an FDA 510(k) premarket notification submitted by Grass-Telefactor Product Group for the device "MODAC-XXXX INTENSIVE MONITORING OF EEG". The FDA issued a decision of Substantially Equivalent on March 27, 1986. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Grass-Telefactor Product Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1986
Date Received
January 14, 1986
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 Grass-Telefactor Product Group

  • K992291 — H20- TETHERED OPTION (August 6, 1999)
  • K974583 — DEEGLITE (June 9, 1998)
  • K974587 — H2O (March 9, 1998)
  • K972202 — DEEG-LITE (July 23, 1997)
  • K925838 — TELEFACTOR D/EEG-32 (April 30, 1993)
  • K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
  • K870432 — A1-A2 AMBULATORY EEG CASSETTE RECORDER (May 8, 1987)
  • K871480 — STD-228 SPECTRAL TREND DISPLAY (May 1, 1987)
  • K870450 — SZAC-16 SEIZURE ANALYSIS COMPUTER (April 8, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)

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)
  • 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)
  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)

FDA data resources