Question 1

Who is the manufacturer of INCENTIVE SPIROMETER?

Accepted Answer

Engineered Medical Systems filed the 510(k) submission for INCENTIVE SPIROMETER (K000314).

Question 2

What is the FDA product code for INCENTIVE SPIROMETER?

Accepted Answer

BWF. It is classified under 21 CFR 868.5690 as a Class 2 device in the Anesthesiology panel.

Question 3

When was INCENTIVE SPIROMETER cleared by the FDA?

Accepted Answer

Apr 12, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for INCENTIVE SPIROMETER?

Accepted Answer

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

Question 5

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

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	K000314
Device Name	INCENTIVE SPIROMETER
Applicant	Engineered Medical Systems
Product Code	BWF · Anesthesiology
Decision Date	Apr 12, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5690
Device Class	Class 2

INCENTIVE SPIROMETER

Device Facts

Regulatory Classification

Identification