Question 1

Who is the manufacturer of MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT?

Accepted Answer

Intl. Ophthalmic Industries Corp. filed the 510(k) submission for MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT (K894511).

Question 2

What is the FDA product code for MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT?

Accepted Answer

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

Question 3

When was MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT cleared by the FDA?

Accepted Answer

Oct 17, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT?

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	K894511
Device Name	MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
Applicant	Intl. Ophthalmic Industries Corp.
Product Code	HQC · Ophthalmic
Decision Date	Oct 17, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2

MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT

Device Facts

Regulatory Classification

Identification