Biore CP-100 Cardiopulmonary Monitor

FDA 510(k) K900696 · Bicore Monitoring Systems

Substantially Equivalent

510(k) numberK900696

Submission

Device name
Biore CP-100 Cardiopulmonary Monitor
Applicant
Bicore Monitoring Systems
Irvine, CA, US
Received
February 13, 1990
Decision date
November 29, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZC – Calculator, Pulmonary Function Data
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1880
Specialty
Anesthesiology

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Questions and answers

When was Biore CP-100 Cardiopulmonary Monitor cleared by the FDA?

Biore CP-100 Cardiopulmonary Monitor (K900696) received a 510(k) decision of Substantially Equivalent on November 29, 1990, 289 days after the submission was received.

What is the product code of K900696?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.