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510(k) K022249

NIGHTRON POLYSOMNOGRAPHY SYSTEM by Telediagnostic Systems, Inc. — Product Code OLV

K022249 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "NIGHTRON POLYSOMNOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 31, 2002. The device falls under product code OLV (Standard Polysomnograph With Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Telediagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2002
Date Received
July 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Standard Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

Other clearances by Telediagnostic Systems, Inc.

  • K071661 — ALPHAONE BIOFEEDBACK SYSTEM (September 5, 2007)
  • K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (May 16, 1997)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K904222 — VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER (January 18, 1991)
  • K885328 — RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER (March 22, 1989)
  • K884891 — OC-100 OXIMETER INTERFACE CALIBRATOR (December 28, 1988)
  • K883947 — ISO-100 ISOLATION AMPLIFIER (December 5, 1988)
  • K874257 — S-10 TELEPHONIC POLYSOMNOGRAPH (December 11, 1987)
  • K871120 — M10 EEG MONITOR SCOPE (May 1, 1987)
  • K810872 — EEG TELEPHONE RECEIVER MODEL #AFR-J (May 1, 1981)

Other clearances for product code OLV

  • K260585 — Noxturnal Web (March 20, 2026)
  • K242447 — Falcon HST (February 20, 2025)
  • K241288 — Noxturnal Web (December 23, 2024)
  • K240700 — HomeSleepTest (HST, HST REM+) (December 8, 2024)
  • K213007 — Cerebra Sleep System (July 6, 2022)
  • K201054 — SOMNOscreen plus (August 12, 2020)
  • K192624 — ApneaTrak (February 20, 2020)
  • K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor (November 16, 2018)
  • K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
  • K173690 — Grass TWin (March 9, 2018)

FDA data resources