Question 1

Who is the manufacturer of MICRO MASKER?

Accepted Answer

Associated Hearing Instruments filed the 510(k) submission for MICRO MASKER (K924991).

Question 2

What is the FDA product code for MICRO MASKER?

Accepted Answer

KLW. It is classified under 21 CFR 874.3400 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was MICRO MASKER cleared by the FDA?

Accepted Answer

Jun 14, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for MICRO MASKER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like MICRO MASKER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K924991
Device Name	MICRO MASKER
Applicant	Associated Hearing Instruments
Product Code	KLW · Ear, Nose, Throat
Decision Date	Jun 14, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3400
Device Class	Class 2

MICRO MASKER

Device Facts

Regulatory Classification

Identification

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