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510(k) K951255

IMEDGE VIDEO OSTOSCOPE (ANALOG) by Introspect, Inc. — Product Code ERA

K951255 is an FDA 510(k) premarket notification submitted by Introspect, Inc. for the device "IMEDGE VIDEO OSTOSCOPE (ANALOG)". The FDA issued a decision of Substantially Equivalent on April 13, 1995. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Introspect, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 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.

  • K950983 — IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE (April 12, 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)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)

FDA data resources