Question 1

Who is the manufacturer of SCREENING COMPUTEO SC-20?

Accepted Answer

Cavitron Corp. filed the 510(k) submission for SCREENING COMPUTEO SC-20 (K771371).

Question 2

What is the FDA product code for SCREENING COMPUTEO SC-20?

Accepted Answer

BZM. It is classified under 21 CFR 868.1900 as a Class 2 device in the Anesthesiology panel.

Question 3

When was SCREENING COMPUTEO SC-20 cleared by the FDA?

Accepted Answer

Aug 4, 1977 (decision: SESE).

Question 4

What is the regulatory pathway for SCREENING COMPUTEO SC-20?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SCREENING COMPUTEO SC-20?

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	K771371
Device Name	SCREENING COMPUTEO SC-20
Applicant	Cavitron Corp.
Product Code	BZM · Anesthesiology
Decision Date	Aug 4, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1900
Device Class	Class 2

SCREENING COMPUTEO SC-20

Device Facts

Regulatory Classification

Identification