MODEL#1550 Marsona(R) Tinnitus Masker

FDA 510(k) K940567 · Marpac, Inc.

Substantially Equivalent

510(k) numberK940567

Submission

Device name
MODEL#1550 Marsona(R) Tinnitus Masker
Applicant
Marpac, Inc.
Wilmington, NC, US
Received
February 8, 1994
Decision date
July 6, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)KLW · Traditional Duearity AB06/30/2023SE
K221168Tinnitogram Signal GeneratorKLW · Traditional Goldenear Company, Inc.02/01/2023SE
K221125SilentCloudKLW · Traditional Aureliym GmbH01/04/2023SE
K201370Multiflex Tinnitus TechnologyKLW · Special Starkey Laboratories, Inc.06/19/2020SE
K193303Tinnitus Sound Generator ModuleKLW · Special GN Hearing A/S02/20/2020SE
K180495Tinnitus Sound Generator ModuleKLW · Traditional GN Hearing A/S11/30/2018SE
K181586Tinnitus Sound Generator ModuleKLW · Special GN Hearing A/S07/13/2018SE

More from GN Hearing A/S

510(k)DeviceDecision
K041485Marpac Messenger Model #501JOH · Traditional 08/02/2004SE
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Questions and answers

When was MODEL#1550 Marsona(R) Tinnitus Masker cleared by the FDA?

MODEL#1550 Marsona(R) Tinnitus Masker (K940567) received a 510(k) decision of Substantially Equivalent on July 6, 1994, 148 days after the submission was received.

What is the product code of K940567?

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