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

Sheet, Recording, Breast Examination

21 CFR 884.2990 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

NHM is the FDA product code for Sheet, Recording, Breast Examination, a class II device type, regulated under 21 CFR 884.2990. FDA's definition for this code reads: "This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NHM
Device name
Sheet, Recording, Breast Examination
FDA definition
This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination.
Regulation
21 CFR 884.2990
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NHM

By decision year
2 clearances under product code NHM with a decision year between 2002 and 2002, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NHM by decision year
YearClearances
20022

Applicants with the most clearances

Product code NHM
Applicants holding the most 510(k) clearances under product code NHM
ApplicantClearances
James D Rusin MD, MBA1
Rusin Medical Devices1

Companies listing this code with FDA

Companies whose registered establishments list this code

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