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LDS · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6991

Classification

FDA Product Code
LDS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.6991
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
11
Registered establishments
10

Source

Authoritative
FDA Device Classification database
Machine
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