Question 1

Who is the manufacturer of CILAS MODEL YM101?

Accepted Answer

Inframed, Inc. filed the 510(k) submission for CILAS MODEL YM101 (K852761).

Question 2

What is the FDA product code for CILAS MODEL YM101?

Accepted Answer

LLO. It is classified under 21 CFR 874.4500 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was CILAS MODEL YM101 cleared by the FDA?

Accepted Answer

Nov 14, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for CILAS MODEL YM101?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CILAS MODEL YM101?

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	K852761
Device Name	CILAS MODEL YM101
Applicant	Inframed, Inc.
Product Code	LLO · Ear, Nose, Throat
Decision Date	Nov 14, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4500
Device Class	Class 2

CILAS MODEL YM101

Device Facts

Regulatory Classification

Identification