OMV · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2770
Classification
FDA Product Code
OMV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2770
Review panel
GU
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.