Product code CBO— Anesthesiology

FALL-SAFE IMV #M-511

Classification name
Attachment, Intermittent Mandatory Ventilation (Imv)
Device class
Class 2
Regulation
21 CFR 868.5955
Advisory panel
Anesthesiology
Total cleared
15
First cleared
Most recent

Market context for product code CBO

FDA has cleared 15 devices under product code CBO between 1976 and 1981, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code CBO

Recent clearances under product code CBO

Data sourced from openFDA. This site is unofficial and independent of the FDA.