Bedside Tinnitus Masker #1500

FDA 510(k) K802234 · Marpac, Inc.

Substantially Equivalent

510(k) numberK802234

Submission

Device name
Bedside Tinnitus Masker #1500
Applicant
Marpac, Inc.
Mchenry, IL, US
Received
September 15, 1980
Decision date
October 10, 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

Other 510(k)s with product code KLW

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K260413Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional Levo Medical Corporation08/13/2026SE
K260614Tinnitus TherapyKLW · Special Sivantos GmbH06/10/2026SE
K233435Peace N Quiet (0.7.0)KLW · Traditional Pnq Health02/27/2024SE
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
K940567MODEL#1550 Marsona(R) Tinnitus MaskerKLW · Traditional 07/06/1994SE

Questions and answers

When was Bedside Tinnitus Masker #1500 cleared by the FDA?

Bedside Tinnitus Masker #1500 (K802234) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 25 days after the submission was received.

What is the product code of K802234?

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