FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Maxxi Flow Sensor
K Number: K201495
·
Decision Dec 14, 2020
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
8
Review Days
192
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Basic Information
- Device Name
- Maxxi Flow Sensor
- K Number
- K201495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurovirtual USA, Inc.
- Date Received
- June 5, 2020
- Decision Date
- December 14, 2020
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Neurovirtual USA, Inc.
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|---|---|---|---|
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| K171304 | Maxxi Rip Sensor | Jun 24, 2019 | Substantially Equivalent |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | Apr 11, 2017 | Substantially Equivalent |
| K131335 | BWMINI EEG, BWMINIHST, BWMINI PSG | Feb 3, 2015 | Substantially Equivalent |
| K112107 | BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS | Oct 28, 2011 | Substantially Equivalent |
| K062533 | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 | Dec 22, 2006 | Substantially Equivalent |