Question 1

Who is the manufacturer of VITALMAX 4000/MINIPACK 3100/3000?

Accepted Answer

Pace Tech, Inc. filed the 510(k) submission for VITALMAX 4000/MINIPACK 3100/3000 (K951226).

Question 2

What is the FDA product code for VITALMAX 4000/MINIPACK 3100/3000?

Accepted Answer

DSK. It is classified under 21 CFR 870.1110 as a Class 2 device in the Cardiovascular panel.

Question 3

When was VITALMAX 4000/MINIPACK 3100/3000 cleared by the FDA?

Accepted Answer

Nov 21, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for VITALMAX 4000/MINIPACK 3100/3000?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like VITALMAX 4000/MINIPACK 3100/3000?

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	K951226
Device Name	VITALMAX 4000/MINIPACK 3100/3000
Applicant	Pace Tech, Inc.
Product Code	DSK · Cardiovascular
Decision Date	Nov 21, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1110
Device Class	Class 2

VITALMAX 4000/MINIPACK 3100/3000

Device Facts

Regulatory Classification

Identification