Question 1

Who is the manufacturer of 629V SPIROMETER, PULMONARY FUNCTION ANALYZER?

Accepted Answer

American Electromedics Corp. filed the 510(k) submission for 629V SPIROMETER, PULMONARY FUNCTION ANALYZER (K881402).

Question 2

What is the FDA product code for 629V SPIROMETER, PULMONARY FUNCTION ANALYZER?

Accepted Answer

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

Question 3

When was 629V SPIROMETER, PULMONARY FUNCTION ANALYZER cleared by the FDA?

Accepted Answer

Sep 26, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for 629V SPIROMETER, PULMONARY FUNCTION ANALYZER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like 629V SPIROMETER, PULMONARY FUNCTION ANALYZER?

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	K881402
Device Name	629V SPIROMETER, PULMONARY FUNCTION ANALYZER
Applicant	American Electromedics Corp.
Product Code	BZG · Anesthesiology
Decision Date	Sep 26, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

629V SPIROMETER, PULMONARY FUNCTION ANALYZER

Device Facts

Regulatory Classification

Identification