OTOGRAM— 510(k) K041853

Substantially Equivalent

Tympany, Inc.

FDA 510(k) clearance K041853 for OTOGRAM, Substantially Equivalent on 2004-09-03. Applicant: Tympany, Inc.. Device class: 2.

Clearance details

Applicant: Tympany, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 2004-07-08
Decision date: 2004-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETW

K122028 — AURICAL HIT2012-10-23
K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT2012-04-19
K110286 — GN OTOMETRICS TYPE 1053 FREEFIT2011-04-28
K093006 — FONIX ,MODEL 80002009-12-30
K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)2007-06-05

More clearances from Tympany, Inc.

K070118 — OTOGRAM, CA33502007-03-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.