510(k) K193311
- Device
- Aluna
- Applicant
- Knox Medical Diagnostics, Inc.
- 510(k) number
- K193311
- Product code
- BZH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-25
- Date received
- 2019-11-29
- 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
Applicant Contact#
- Contact
- Charvi Shetty
- Address
- 345 California St., Suite 600 San Francisco CA US 94104 94104
FDA Registration Numbers#
- 3034603279
- 8020605
- 3014335097
- 3007134734
- 3030626362
- 9610639
- 3018783526
- 8043316
- 9614860
- 9710567
- 3023412068
- 1450057
- 9612777
- 3009746061
- 3004157007
- 3010272829
- 3000126629
- 2518422
- 9680225
- 3003993690
- 9615102
- 3017202422
- 3016670256
- 3030446844
- 3004111573
- 3023272766
- 3017520431
- 3021235837
- 3004050971
- 3012494290
- 3010830834
- 3016218294
- 3038562397
- 3002808458
- 1317346
- 3004748541
- 3004087544
- 3008505660
- 1000604079
- 2022648
- 3004541594
Source Documents#
Other 510(k) Records For Product Code BZH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 |
| K241338 | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| K232588 | Aluna 2 | Knox Medical Diagnostics | 2024-11-25 |
| K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 |
| K222810 | TD-7301 Peak Flow meter | Gostar Co., Ltd. | 2023-12-19 |
| K203196 | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 |
| K200832 | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| K191239 | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 |
| K180487 | Peak.me | Breathe Me, Ltd. | 2018-10-26 |
| K181666 | Smart One | Mir Medical International Research | 2018-08-01 |
| K172804 | Besmed Peak Flow Meter | Besmed Health Business Corp | 2018-01-11 |
| K170281 | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 |
| K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016-06-03 |
| K133975 | MSA100 PEAK FLOW METER | Beijing M&B Electronic Instruments Co., Ltd. | 2014-10-03 |
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Monaghan Medical Corp. | 2013-04-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases