Nuvox Bedside Tinnitus Masker

FDA 510(k) K802750 · Hal-Hen Co., Inc.

Substantially Equivalent

510(k) numberK802750

Submission

Device name
Nuvox Bedside Tinnitus Masker
Applicant
Hal-Hen Co., Inc.
Mchenry, IL, US
Received
November 4, 1980
Decision date
December 31, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KLW – Masker, Tinnitus
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3400
Specialty
Ear, Nose, Throat

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Questions and answers

When was Nuvox Bedside Tinnitus Masker cleared by the FDA?

Nuvox Bedside Tinnitus Masker (K802750) received a 510(k) decision of Substantially Equivalent on December 31, 1980, 57 days after the submission was received.

What is the product code of K802750?

The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.