Question 1

Who is the manufacturer of PLOTTER FOR AS-500?

Accepted Answer

Riko Medical & Scientific Instrument Corp. filed the 510(k) submission for PLOTTER FOR AS-500 (K853922).

Question 2

What is the FDA product code for PLOTTER FOR AS-500?

Accepted Answer

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

Question 3

When was PLOTTER FOR AS-500 cleared by the FDA?

Accepted Answer

Nov 14, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for PLOTTER FOR AS-500?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PLOTTER FOR AS-500?

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	K853922
Device Name	PLOTTER FOR AS-500
Applicant	Riko Medical & Scientific Instrument Corp.
Product Code	BZH · Anesthesiology
Decision Date	Nov 14, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1860
Device Class	Class 2

PLOTTER FOR AS-500

Device Facts

Regulatory Classification

Identification