Who is the manufacturer of SPIROTEQ?

System Analysis Corp. filed the 510(k) submission for SPIROTEQ (K894556).

What is the FDA product code for SPIROTEQ?

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

What is the regulatory pathway for SPIROTEQ?

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

Who can help prepare an FDA 510(k) submission like SPIROTEQ?

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.

SPIROTEQ

K894556 · System Analysis Corp. · BZG · Jan 9, 1990 · Anesthesiology

Device Facts

Record ID	K894556
Device Name	SPIROTEQ
Applicant	System Analysis Corp.
Product Code	BZG · Anesthesiology
Decision Date	Jan 9, 1990
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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