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

Device, Muscle Monitoring

21 CFR 890.1375 / Physical Medicine
FDA source (opens on fda.gov)

KZM is the FDA product code for Device, Muscle Monitoring, a class II device type, regulated under 21 CFR 890.1375. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KZM
Device name
Device, Muscle Monitoring
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
0

Clearances, product code KZM

By decision year
19 clearances under product code KZM with a decision year between 1981 and 2016, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KZM by decision year
YearClearances
19811
19831
19862
19871
19881
19931
19942
19981
19991
20001
20011
20041
20051
20091
20121
20131
20161

Applicants with the most clearances

Product code KZM
Applicants holding the most 510(k) clearances under product code KZM
ApplicantClearances
Bio-Research Associates, Inc.5
Myo-Tronics, Inc.3
Myo-Tronics Research, Inc.2
Myotronics-Noromed, Inc.2
Bts S.p.A.1
Electronic Waveform Laboratory, Inc.1
M. D. Supply, Inc.1
Medotech A/S1
Neuromuscular Technologies, Inc.1
Pain Prevention, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code