← FDA Medical Device Classifications

Monitor, Heart Sound, Fetal, Ultrasonic

HEK · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.2660

Classification

FDA Product Code

HEK

Device class

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

Regulation

21 CFR 884.2660

Review panel

OB

Medical specialty

Obstetrics/Gynecology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

5

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

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