Home / 510(k) Clearances / K792371

510(k) K792371

TELEMETRY SYSTEM XMT-1 & REC-1 by Burdick Corp. — Product Code GYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1980
Date Received
November 26, 1979
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 Burdick Corp.

  • K952417 — QUEST EXERCISE STRESS SYSTEM (May 22, 1996)
  • K954267 — BURDICK 200 PULSE OXIMETER (May 3, 1996)
  • K946281 — ECLIPSE 4 ELECTROCARDIOGRAPH (April 23, 1996)
  • K945985 — PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (July 3, 1995)
  • K943959 — ECLIPSE 4 ELECTROCARDIOGRAPH (May 17, 1995)
  • K942565 — ALTAIR-DISC RECORDER (December 5, 1994)
  • K941351 — BURDICK PRO2 OXIMETER (October 13, 1994)
  • K942438 — ALTAIR 6100 CASSETTE RECORDER (August 5, 1994)
  • K903565 — E560 ELECTROCARDIOGRAPH (July 24, 1991)
  • K904032 — ELITE II ELECTROCARDIOGRAPH (July 24, 1991)

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)