Question 1

Who is the manufacturer of VITALMAX 800-C?

Accepted Answer

Pace Tech, Inc. filed the 510(k) submission for VITALMAX 800-C (K930559).

Question 2

What is the FDA product code for VITALMAX 800-C?

Accepted Answer

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

Question 3

When was VITALMAX 800-C cleared by the FDA?

Accepted Answer

Sep 3, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for VITALMAX 800-C?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like VITALMAX 800-C?

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	K930559
Device Name	VITALMAX 800-C
Applicant	Pace Tech, Inc.
Product Code	CCK · Anesthesiology
Decision Date	Sep 3, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2

VITALMAX 800-C

Device Facts

Regulatory Classification

Identification