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

Monitor, Spinal-Fluid Pressure, Electrically Powered

21 CFR 880.2460 / General Hospital
FDA source (opens on fda.gov)

CAR is the FDA product code for Monitor, Spinal-Fluid Pressure, Electrically Powered, a class II device type, regulated under 21 CFR 880.2460. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CAR
Device name
Monitor, Spinal-Fluid Pressure, Electrically Powered
Regulation
21 CFR 880.2460
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code CAR

By decision year
3 clearances under product code CAR with a decision year between 1992 and 1994, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CAR by decision year
YearClearances
19921
19931
19941

Applicants with the most clearances

Product code CAR
Applicants holding the most 510(k) clearances under product code CAR
ApplicantClearances
Bion Ent., Ltd.1
Impra, Inc.1
Industrias Palex C/O Dma Med-Chem Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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