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510(k) K150163

Otowave 202 Portable Tympanometer by Amplivox, Ltd. — Product Code NAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2015
Date Received
January 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tympanometer
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

Other clearances by Amplivox, Ltd.

  • K171265 — Otowave 302 Portable Tympanometer (July 28, 2017)
  • K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (July 16, 2008)

Other clearances for product code NAS

  • K171265 — Otowave 302 Portable Tympanometer (July 28, 2017)