Question 1

Who is the manufacturer of DATASCOPE MULTINEX II?

Accepted Answer

Datascope Corp. filed the 510(k) submission for DATASCOPE MULTINEX II (K926451).

Question 2

What is the FDA product code for DATASCOPE MULTINEX II?

Accepted Answer

CBQ. It is classified under 21 CFR 868.1500 as a Class 2 device in the Anesthesiology panel.

Question 3

When was DATASCOPE MULTINEX II cleared by the FDA?

Accepted Answer

Aug 25, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for DATASCOPE MULTINEX II?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DATASCOPE MULTINEX II?

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	K926451
Device Name	DATASCOPE MULTINEX II
Applicant	Datascope Corp.
Product Code	CBQ · Anesthesiology
Decision Date	Aug 25, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1500
Device Class	Class 2

DATASCOPE MULTINEX II

Device Facts

Regulatory Classification

Identification