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510(k) K123821

AIO HD OTOSCOPE by Blue Focus — Product Code ERA

K123821 is an FDA 510(k) premarket notification submitted by Blue Focus for the device "AIO HD OTOSCOPE". The FDA issued a decision of Substantially Equivalent on May 17, 2013. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2013
Date Received
December 12, 2012
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 for product code ERA

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

FDA data resources