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510(k) K811093

BRAEGEN EEG TRANSMITTER/RECEIVER SYS by Electro-Bio-Medical Services, Inc. — Product Code GYE

K811093 is an FDA 510(k) premarket notification submitted by Electro-Bio-Medical Services, Inc. for the device "BRAEGEN EEG TRANSMITTER/RECEIVER SYS". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Electro-Bio-Medical Services, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
April 21, 1981
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 Electro-Bio-Medical Services, Inc.

  • K832304 — BRAEGEN III 10-CHANNEL TRANSMITTER- (August 31, 1983)

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)
  • K860128 — MODAC-XXXX INTENSIVE MONITORING OF EEG (March 27, 1986)

FDA data resources