510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QYFClass II

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

21 CFR 870.1130 / Cardiovascular
FDA source (opens on fda.gov)

QYF is the FDA product code for Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms), a class II device type, regulated under 21 CFR 870.1130. FDA's definition for this code reads: "The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QYF
Device name
Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)
FDA definition
The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring.
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QYF.