Device classification

Monitor, Heart Sound, Fetal, Ultrasonic

Obstetrics/Gynecology · 21 CFR 884.2660

Class IIProduct code HEK
Open FDA's page for this record
Third party flag
Y
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Ineligible
Product code
HEK
Review panel
OB
Medical specialty
OB
Device name
Monitor, Heart Sound, Fetal, Ultrasonic
Medical specialty description
Obstetrics/Gynecology
Device class
2
Regulation number
884.2660
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K883334, K771211, K142769, K060410, K902190
Registration number
3020115, 1216677
FEI number
3020115, 1216677
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.