FDA.report

510(k) K232588

Device
Aluna 2
Applicant
Knox Medical Diagnostics
510(k) number
K232588
Product code
BZH
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-25
Date received
2023-08-25
Regulation
868.1860
Classification name
Meter, Peak Flow, Spirometry
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Michael Raftery
Address
650 California St., Floor 7 San Francisco CA US 94108 94108

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd.2021-05-26
K200832Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd.2020-07-30
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K170281MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd.2017-10-06
K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc.2016-06-03
K133975MSA100 PEAK FLOW METERBeijing M&B Electronic Instruments Co., Ltd.2014-10-03
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