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JEH · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1760

Classification

FDA Product Code
JEH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.1760
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y

Market data

Cleared 510(k) submissions
11
Registered establishments
8

Source

Authoritative
FDA Device Classification database
Machine
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