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510(k) K833880

TELEPHONIC RECEIVER R-10 EEG by Pharmaquest Corp. — Product Code GYE

K833880 is an FDA 510(k) premarket notification submitted by Pharmaquest Corp. for the device "TELEPHONIC RECEIVER R-10 EEG". The FDA issued a decision of Substantially Equivalent on November 29, 1983. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Pharmaquest Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1983
Date Received
November 16, 1983
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 Pharmaquest Corp.

  • K945519 — FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE AN (November 3, 1995)
  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)
  • K830705 — MINI LANCET-BLOOD LANCET (April 8, 1983)
  • K822976 — HYPOCOUNT A (November 16, 1982)
  • K822486 — HOME BLOOD GLUCOSE MONITOR (November 5, 1982)
  • K820248 — RODDER VOLUME VENTILATOR (April 16, 1982)
  • K812849 — PTT-200 TELEPHONIC PULMONARY TRANSMITT (December 3, 1981)
  • K812850 — PTT-200 PULMONARY RECEIVER/MICROPROCES (December 3, 1981)
  • K813010 — EEG TELEPHONE TRANSMITTER, MODEL #T-7 (November 16, 1981)
  • K812683 — NEONATE FLEXFLOAT (October 13, 1981)

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