510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150163Substantially Equivalent

Otowave 202 Portable Tympanometer

Amplivox Ltd, Eynsham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150163 is the FDA 510(k) clearance record for Otowave 202 Portable Tympanometer, a class II device, cleared for Amplivox, Ltd. on under FDA product code NAS (Tympanometer). FDA records list 3 510(k) clearances for Amplivox, Ltd., from to . As of , FDA records show no recalls naming K150163.

Clearance record

Decision date
Received
(87 days to decision)
Product code
NAS Tympanometer
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Amplivox, Ltd. 6 Oasis Park, Eynsham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAS

Trailing 12 months

FDA records hold no clearances under product code NAS in the trailing twelve months.

FDA records show no clearances under product code NAS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260