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
JAFClass II

Monitor, Ultrasonic, Nonfetal

21 CFR 892.1540 / Radiology
FDA source (opens on fda.gov)

JAF is the FDA product code for Monitor, Ultrasonic, Nonfetal, a class II device type, regulated under 21 CFR 892.1540. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
JAF
Device name
Monitor, Ultrasonic, Nonfetal
Regulation
21 CFR 892.1540
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
38
Ingested recalls
8

Clearances, product code JAF

By decision year
38 clearances under product code JAF with a decision year between 1978 and 2024, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JAF by decision year
YearClearances
19782
19803
19821
19841
19854
19862
19881
19901
19912
19921
19942
19952
19961
19972
19982
20011
20051
20062
20071
20081
20092
20111
20151
20241

Applicants with the most clearances

Product code JAF
Applicants holding the most 510(k) clearances under product code JAF
ApplicantClearances
Imex Medical Systems, Inc.3
Biomedix Wai2
Kt Medical, Inc.2
L&M Ultrascope Life Monitoring Sys.2
Medasonics, Inc.2
Nicolet Biomedical, Inc.2
Philips North America LLC2
Summit Doppler Systems, Inc.2
Thd SpA2
Accra Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code