← FDA Medical Device Classifications

Patient Monitor With Independent Remote Display And Operation

QLJ · Not classified · Unknown

Classification

FDA Product Code
QLJ
Device class
Not classified
Regulation
Review panel
CV
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Monitors intended for the remote display and operation of patient physiological monitors, including alarm functionality, signal analysis, and data recording during declared public health emergency.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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