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510(k) K950983

IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE by Introspect, Inc. — Product Code ERA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1995
Date Received
March 3, 1995
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 Introspect, Inc.

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

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)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)