Question 1

Who is the manufacturer of PERSONAL BEST II?

Accepted Answer

Healthscan Products, Inc. filed the 510(k) submission for PERSONAL BEST II (K962929).

Question 2

What is the FDA product code for PERSONAL BEST II?

Accepted Answer

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

Question 3

When was PERSONAL BEST II cleared by the FDA?

Accepted Answer

Oct 24, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for PERSONAL BEST II?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PERSONAL BEST 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	K962929
Device Name	PERSONAL BEST II
Applicant	Healthscan Products, Inc.
Product Code	BZH · Anesthesiology
Decision Date	Oct 24, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1860
Device Class	Class 2

PERSONAL BEST II

Device Facts

Regulatory Classification

Identification