Question 1

Who is the manufacturer of COMPUTER AUDIOMETER - MA26?

Accepted Answer

Maico Hearing Instruments, Inc. filed the 510(k) submission for COMPUTER AUDIOMETER - MA26 (K780270).

Question 2

What is the FDA product code for COMPUTER AUDIOMETER - MA26?

Accepted Answer

EWO. It is classified under 21 CFR 874.1050 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was COMPUTER AUDIOMETER - MA26 cleared by the FDA?

Accepted Answer

Feb 27, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for COMPUTER AUDIOMETER - MA26?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like COMPUTER AUDIOMETER - MA26?

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	K780270
Device Name	COMPUTER AUDIOMETER - MA26
Applicant	Maico Hearing Instruments, Inc.
Product Code	EWO · Ear, Nose, Throat
Decision Date	Feb 27, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1050
Device Class	Class 2

COMPUTER AUDIOMETER - MA26

Device Facts

Regulatory Classification

Identification