FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
Hailie Sensor NF0107 & NF0108
K Number: K221994
·
Decision Oct 4, 2022
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
10
Review Days
90
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Basic Information
- Device Name
- Hailie Sensor NF0107 & NF0108
- K Number
- K221994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Adherium (Nz), Ltd.
- Date Received
- July 6, 2022
- Decision Date
- October 4, 2022
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Adherium (Nz), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K222247 | Hailie Sensor NF0110 | Feb 8, 2023 | Substantially Equivalent |
| K220622 | Hailie Sensor NF0106 | Jul 15, 2022 | Substantially Equivalent |
| K211233 | Hailie Sensor NF0109 | Aug 18, 2021 | Substantially Equivalent |
| K182638 | Hailie Sensor | Jun 19, 2019 | Substantially Equivalent |
| K182573 | Hailie Sensor | Jun 7, 2019 | Substantially Equivalent |
| K181405 | Hailie Sensor | Dec 10, 2018 | Substantially Equivalent |
| K180407 | Smartinhaler | Jul 25, 2018 | Substantially Equivalent |
| K173310 | SmartTouch | Mar 26, 2018 | Substantially Equivalent |
| K163485 | SmartTouch | Aug 30, 2017 | Substantially Equivalent |