← FDA Medical Device Classifications

Monitor, Esophageal Motility, Anorectal Motility, And Tube

KLA · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1725

Classification

FDA Product Code

KLA

Device class

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

Regulation

21 CFR 876.1725

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

31

Registered establishments

14

Source

Authoritative

FDA Device Classification database

Machine

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