Question 1

Who is the manufacturer of RESPIRATORY ASSESSMENT SYSTEM?

Accepted Answer

Thoratec Laboratories Corp. filed the 510(k) submission for RESPIRATORY ASSESSMENT SYSTEM (K833714).

Question 2

What is the FDA product code for RESPIRATORY ASSESSMENT SYSTEM?

Accepted Answer

BZL. It is classified under 21 CFR 868.1730 as a Class 2 device in the Anesthesiology panel.

Question 3

When was RESPIRATORY ASSESSMENT SYSTEM cleared by the FDA?

Accepted Answer

Dec 29, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for RESPIRATORY ASSESSMENT SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like RESPIRATORY ASSESSMENT SYSTEM?

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	K833714
Device Name	RESPIRATORY ASSESSMENT SYSTEM
Applicant	Thoratec Laboratories Corp.
Product Code	BZL · Anesthesiology
Decision Date	Dec 29, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1730
Device Class	Class 2

RESPIRATORY ASSESSMENT SYSTEM

Device Facts

Regulatory Classification

Identification