Question 1

Who is the manufacturer of BIORE CP-100 CARDIOPULMONARY MONITOR?

Accepted Answer

Bicore Monitoring Systems filed the 510(k) submission for BIORE CP-100 CARDIOPULMONARY MONITOR (K900696).

Question 2

What is the FDA product code for BIORE CP-100 CARDIOPULMONARY MONITOR?

Accepted Answer

BZC. It is classified under 21 CFR 868.1880 as a Class 2 device in the Anesthesiology panel.

Question 3

When was BIORE CP-100 CARDIOPULMONARY MONITOR cleared by the FDA?

Accepted Answer

Nov 29, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for BIORE CP-100 CARDIOPULMONARY MONITOR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like BIORE CP-100 CARDIOPULMONARY MONITOR?

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	K900696
Device Name	BIORE CP-100 CARDIOPULMONARY MONITOR
Applicant	Bicore Monitoring Systems
Product Code	BZC · Anesthesiology
Decision Date	Nov 29, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1880
Device Class	Class 2

BIORE CP-100 CARDIOPULMONARY MONITOR

Device Facts

Regulatory Classification

Identification