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510(k) K780150

NEONATAL SCREENING AUDIOMETER by Telediagnostic Systems, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1978
Date Received
January 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Telediagnostic Systems, Inc.

  • K071661 — ALPHAONE BIOFEEDBACK SYSTEM (September 5, 2007)
  • K022249 — NIGHTRON POLYSOMNOGRAPHY SYSTEM (December 31, 2002)
  • 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)

Other clearances for product code EWO

  • K234095 — OtoNova/OtoNova Pro (June 21, 2024)
  • K240430 — Otoport Pro (March 15, 2024)
  • K231545 — hearOAE (October 27, 2023)
  • K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na (June 22, 2022)
  • K191372 — Lyra (July 15, 2019)
  • K180287 — GSI Corti (May 11, 2018)
  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)