Question 1

Who is the manufacturer of KPE 230 AM?

Accepted Answer

Ipax, Inc. filed the 510(k) submission for KPE 230 AM (K914172).

Question 2

What is the FDA product code for KPE 230 AM?

Accepted Answer

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

Question 3

When was KPE 230 AM cleared by the FDA?

Accepted Answer

Oct 25, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for KPE 230 AM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like KPE 230 AM?

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	K914172
Device Name	KPE 230 AM
Applicant	Ipax, Inc.
Product Code	HQC · Ophthalmic
Decision Date	Oct 25, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2

KPE 230 AM

Device Facts

Regulatory Classification

Identification