510(k) K003499
- Device
- REMVIEW SLEEP RECORDER, MODEL 320
- Applicant
- RESPIRONICS, INC.
- 510(k) number
- K003499
- Product code
- LEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-02-09
- Date received
- 2000-11-13
- Regulation
- 882.5050
- Classification name
- Device, Sleep Assessment
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID J VANELLA
- Address
- 1001 Murry Ridge Ln. Murrysville PA US 15668 15668
FDA Registration Numbers#
- 3020018
- 3009503584
- 1930027
- 3008717264
- 3013896610
- 3012302888
- 2430863
- 3004091281
- 3019791389
- 3002912391
- 3033715634
- 3012324979
- 3012933969
- 3014886121
- 3007485597
Source Documents#
Other 510(k) Records For Product Code LEL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252981 | EmbraceMini | Empatica S.r.l. | 2025-12-22 |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | 2025-07-31 |
| K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | 2025-04-16 |
| K233987 | VERABAND™ | Arbor Medical Innovations, LLC | 2024-06-17 |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | 2024-04-03 |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | 2023-06-23 |
| K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | 2018-05-24 |
| K151784 | ActTrust | Condor Instruments Ltda. - Epp | 2016-05-25 |
| K132764 | MOTION WATCH AND PRO-DIARY | Camntech, Ltd. | 2014-01-21 |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | 2011-12-16 |
| K040932 | EASYNET BODY POSITION MODULE | Cadwell Laboratories, Inc. | 2004-07-01 |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Cadwell Laboratories, Inc. | 2004-07-01 |
| K981969 | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | 1998-08-20 |
| K961817 | B SMART MODEL 1 | Koven Technology, Inc. | 1997-07-23 |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Neurim Pharmaceuticals, Ltd. | 1997-07-10 |
Legacy Summary#
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FDA Review#
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