Question 1

Who is the manufacturer of WELCH ALLY OTOSCOPE?

Accepted Answer

Welch Allyn, Inc. filed the 510(k) submission for WELCH ALLY OTOSCOPE (K952578).

Question 2

What is the FDA product code for WELCH ALLY OTOSCOPE?

Accepted Answer

ERA. It is classified under 21 CFR 874.4770 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was WELCH ALLY OTOSCOPE cleared by the FDA?

Accepted Answer

Jul 10, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for WELCH ALLY OTOSCOPE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like WELCH ALLY OTOSCOPE?

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	K952578
Device Name	WELCH ALLY OTOSCOPE
Applicant	Welch Allyn, Inc.
Product Code	ERA · Ear, Nose, Throat
Decision Date	Jul 10, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4770
Device Class	Class 1

WELCH ALLY OTOSCOPE

Device Facts

Regulatory Classification

Identification