Question 1

Who is the manufacturer of OTOVIEW TELESCOPIC OTOSCOPES?

Accepted Answer

Smith & Nephew, Inc. filed the 510(k) submission for OTOVIEW TELESCOPIC OTOSCOPES (K943721).

Question 2

What is the FDA product code for OTOVIEW TELESCOPIC OTOSCOPES?

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 OTOVIEW TELESCOPIC OTOSCOPES cleared by the FDA?

Accepted Answer

Nov 18, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for OTOVIEW TELESCOPIC OTOSCOPES?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like OTOVIEW TELESCOPIC OTOSCOPES?

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	K943721
Device Name	OTOVIEW TELESCOPIC OTOSCOPES
Applicant	Smith & Nephew, Inc.
Product Code	ERA · Ear, Nose, Throat
Decision Date	Nov 18, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4770
Device Class	Class 1

OTOVIEW TELESCOPIC OTOSCOPES

Device Facts

Regulatory Classification

Identification