← FDA Medical Device Classifications

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

JOQ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1750

Classification

FDA Product Code

JOQ

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 870.1750

Review panel

CV

Medical specialty

Cardiovascular

Submission type

1

GMP exempt

N

Life sustaining

Y

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

18

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

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