510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CBAClass II

Monitor, Air Embolism, Ultrasonic

21 CFR 868.2025 / Anesthesiology
FDA source (opens on fda.gov)

CBA is the FDA product code for Monitor, Air Embolism, Ultrasonic, a class II device type, regulated under 21 CFR 868.2025. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
CBA
Device name
Monitor, Air Embolism, Ultrasonic
Regulation
21 CFR 868.2025
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code CBA

By decision year
1 clearance under product code CBA with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CBA by decision year
YearClearances
19781

Applicants with the most clearances

Product code CBA
Applicants holding the most 510(k) clearances under product code CBA
ApplicantClearances
Omp Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CBA.