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510(k) K831614

INSPETOSCOPE by Terayco Intl., Ltd. — Product Code ERA

K831614 is an FDA 510(k) premarket notification submitted by Terayco Intl., Ltd. for the device "INSPETOSCOPE". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Terayco Intl., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
May 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type

Other clearances by Terayco Intl., Ltd.

  • K844624 — BASIS DIGITAL THERMOMETER MODEL BTM-1 (March 21, 1985)
  • K831929 — BASIC BREAST PUMP (September 29, 1983)

Other clearances for product code ERA

  • K123821 — AIO HD OTOSCOPE (May 17, 2013)
  • K121326 — LANTOS 3D EAR SCANNER (January 25, 2013)
  • K110326 — OSRAM ITOS (October 27, 2011)
  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K955043 — WELCH ALLYN BI-OTOSCOPE (November 14, 1995)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)

FDA data resources