Question 1

Who is the manufacturer of COOPER VISION SYSTEM VI U/S MODULE?

Accepted Answer

CooperVision, Inc. filed the 510(k) submission for COOPER VISION SYSTEM VI U/S MODULE (K853070).

Question 2

What is the FDA product code for COOPER VISION SYSTEM VI U/S MODULE?

Accepted Answer

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

Question 3

When was COOPER VISION SYSTEM VI U/S MODULE cleared by the FDA?

Accepted Answer

Aug 20, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for COOPER VISION SYSTEM VI U/S MODULE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like COOPER VISION SYSTEM VI U/S MODULE?

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	K853070
Device Name	COOPER VISION SYSTEM VI U/S MODULE
Applicant	CooperVision, Inc.
Product Code	HQC · Ophthalmic
Decision Date	Aug 20, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2

COOPER VISION SYSTEM VI U/S MODULE

Device Facts

Regulatory Classification

Identification