510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FMJClass II

Manometer, Spinal-Fluid

21 CFR 880.2500 / General Hospital
FDA source (opens on fda.gov)

FMJ is the FDA product code for Manometer, Spinal-Fluid, a class II device type, regulated under 21 CFR 880.2500. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FMJ
Device name
Manometer, Spinal-Fluid
Regulation
21 CFR 880.2500
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
6
Ingested recalls
5

Clearances, product code FMJ

By decision year
6 clearances under product code FMJ with a decision year between 1988 and 2017, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FMJ by decision year
YearClearances
19881
19911
19961
19971
20031
20171

Applicants with the most clearances

Product code FMJ
Applicants holding the most 510(k) clearances under product code FMJ
ApplicantClearances
Ansr Ent., Inc.1
B.Braun Medical, Inc.1
Busse Hospital Disposables1
Megadyne Medical Products, Inc1
Pajunk GmbH Medizintechnologie1
Smiths Industries Medical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code