FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMVIEW SLEEP RECORDER, MODEL 320
K Number: K003499
·
Decision Feb 9, 2001
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
18
Applicant Total
172
Review Days
88
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
- REMVIEW SLEEP RECORDER, MODEL 320
- K Number
- K003499
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- November 13, 2000
- Decision Date
- February 9, 2001
- Product Code
- LEL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LEL | Device, Sleep Assessment | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LEL), ordered by most recent decision date.
EmbraceMini
FDA 510(k)
FDA Class 2
·Neurology
Sleep Watch
FDA 510(k)
FDA Class 2
·Neurology
DCM (PW-DCM)
FDA 510(k)
FDA Class 2
·Neurology
VERABAND
FDA 510(k)
FDA Class 2
·Neurology
Oxevision Sleep Device
FDA 510(k)
FDA Class 2
·Neurology
ActiGraph LEAP activity monitor (ActiGraph LEAP)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Respironics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | Dec 30, 2024 | Substantially Equivalent |
| K231313 | Therapy Mask 3100 NC/SP | Jul 28, 2023 | Substantially Equivalent |
| K210844 | DreamWear Silicone Pillows Mask | Aug 24, 2021 | Substantially Equivalent |
| K210386 | Magneto Nasal Mask | Jul 12, 2021 | Substantially Equivalent |
| K202142 | Sleepware G3 | Oct 29, 2020 | Substantially Equivalent |
| K201439 | Ventilator, Non-continuous (Respirator) | Sep 25, 2020 | Substantially Equivalent |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Jul 10, 2020 | Substantially Equivalent |
| K183226 | Care Orchestrator Essence | Oct 18, 2019 | Substantially Equivalent |
| K183625 | SomnaPatch | Oct 18, 2019 | Substantially Equivalent |
| K181166 | Trilogy Evo | Jul 18, 2019 | Substantially Equivalent |