← FDA Medical Device Classifications

Tools, Pacemaker Service

DTF · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.3730

Classification

FDA Product Code
DTF
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 870.3730
Review panel
CV
Medical specialty
Cardiovascular
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
2
Registered establishments
6

Source

Authoritative
FDA Device Classification database
Machine
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