← FDA Medical Device Classifications

Transducer, Blood-Pressure, Extravascular

DRS · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2850

Classification

FDA Product Code
DRS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2850
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y

Market data

Cleared 510(k) submissions
148
Registered establishments
90

Source

Authoritative
FDA Device Classification database
Machine
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