Who is the manufacturer of B-1000?

Biotrine Corp. filed the 510(k) submission for B-1000 (K844226).

What is the FDA product code for B-1000?

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

What is the regulatory pathway for B-1000?

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

Who can help prepare an FDA 510(k) submission like B-1000?

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.

B-1000

K844226 · Biotrine Corp. · BZG · Nov 20, 1984 · Anesthesiology

Device Facts

Record ID	K844226
Device Name	B-1000
Applicant	Biotrine Corp.
Product Code	BZG · Anesthesiology
Decision Date	Nov 20, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

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