← FDA Medical Device Classifications

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KME · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6060

Classification

FDA Product Code

KME

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 880.6060

Review panel

HO

Medical specialty

General Hospital

Submission type

4

GMP exempt

Y

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

65

Registered establishments

556

Source

Authoritative

FDA Device Classification database

Machine

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