FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Maxxi Snore Sensor
K Number: K191095
·
Decision Jan 16, 2020
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
8
Review Days
266
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Maxxi Snore Sensor
- K Number
- K191095
- 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
- April 25, 2019
- Decision Date
- January 16, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNR), ordered by most recent decision date.
CASSIE
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
WatchPAT400 (WP400)
FDA 510(k)
FDA Class 2
·Anesthesiology
Somfit D
FDA 510(k)
FDA Class 2
·Anesthesiology
Onera STS 2 (ONERA STS 2)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Neurovirtual USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201495 | Maxxi Flow Sensor | Dec 14, 2020 | Substantially Equivalent |
| K191492 | Maxxi Position Sensor | Apr 24, 2020 | Substantially Equivalent |
| 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 |