Question 1

Who is the manufacturer of VIT-O-METER?

Accepted Answer

Health Scan, Inc. filed the 510(k) submission for VIT-O-METER (K820032).

Question 2

What is the FDA product code for VIT-O-METER?

Accepted Answer

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

Question 3

When was VIT-O-METER cleared by the FDA?

Accepted Answer

Feb 10, 1982 (decision: SESE).

Question 4

What is the regulatory pathway for VIT-O-METER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like VIT-O-METER?

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	K820032
Device Name	VIT-O-METER
Applicant	Health Scan, Inc.
Product Code	BZG · Anesthesiology
Decision Date	Feb 10, 1982
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

VIT-O-METER

Device Facts

Regulatory Classification

Identification