Question 1

Who is the manufacturer of MODEL 200?

Accepted Answer

Western Laboratories Corp. filed the 510(k) submission for MODEL 200 (K830468).

Question 2

What is the FDA product code for MODEL 200?

Accepted Answer

FTZ. It is classified under 21 CFR 886.4445 as a Class 1 device in the Ophthalmic panel.

Question 3

When was MODEL 200 cleared by the FDA?

Accepted Answer

Apr 12, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for MODEL 200?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODEL 200?

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	K830468
Device Name	MODEL 200
Applicant	Western Laboratories Corp.
Product Code	FTZ · Ophthalmic
Decision Date	Apr 12, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4445
Device Class	Class 1

MODEL 200

Device Facts

Regulatory Classification

Identification