K232989

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)

510(k) number
K232989
Device name
Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
Applicant
Shenzhen AOJ Medical Technology Co., Ltd. CN
Product code
DQA — Oximeter
Decision date
2024-07-01
Date received
2023-09-22
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain

Also available from FDA: K232989.pdf

Official FDA record: K232989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.