Home / 510(k) Clearances / K945264

510(k) K945264

OPTUS OTOSCOPES by Optus, Inc. — Product Code ERA

K945264 is an FDA 510(k) premarket notification submitted by Optus, Inc. for the device "OPTUS OTOSCOPES". The FDA issued a decision of Substantially Equivalent on February 2, 1996. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Optus, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1996
Date Received
October 28, 1994
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 Optus, Inc.

  • K953913 — OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES (January 22, 1996)
  • K945268 — OPTUS BRONCHOSCOPES (December 21, 1995)
  • K945265 — OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES (September 12, 1995)
  • K945262 — OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (May 26, 1995)
  • K945267 — OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES (May 23, 1995)
  • K945266 — OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES (February 23, 1995)
  • K944656 — OPTUS SINUSCOPES AND ACCESSORIES (January 26, 1995)
  • K945263 — OPTUS THORACOSCOPES (December 13, 1994)
  • K945269 — OPTUS LARYNGOSCOPES (November 7, 1994)

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)
  • 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)
  • K951255 — IMEDGE VIDEO OSTOSCOPE (ANALOG) (April 13, 1995)

FDA data resources