510(k) K050143
- Device
- OMNIPRO SYSTEM
- Applicant
- MAYS AND ASSOCIATES, INC.
- 510(k) number
- K050143
- Product code
- OLV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-01
- Date received
- 2005-01-21
- Regulation
- 882.1400
- Classification name
- Standard Polysomnograph With Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- HARVEY KNAUSS
- Address
- 11874 S. Evelyn Cir. Houston TX US 77071 77071
FDA Registration Numbers#
- 9612330
- 3021736577
- 9613619
- 2080783
- 3026753386
- 3005733633
- 3023272766
- 3013501110
- 3002806730
- 1529102
- 3010611950
- 3009770872
- 3011120183
- 1650946
- 2023374
- 1063925
- 2518422
- 3015491430
- 3007611554
- 3012428212
- 3007323246
- 3005550372
- 3007962724
- 3002797442
- 8030229
- 3007389703
- 9617286
- 3006125362
- 3038562397
- 9611252
- 3016852448
- 3006418479
- 3027726372
- 3007616088
- 2184161
- 3008881376
- 3038189172
- 3001687738
- 3030154814
- 1530224
- 9710486
- 3006258337
- 3018783526
- 3020018
- 3004964738
- 3000126629
- 9615102
- 3006177498
- 3008253300
Source Documents#
Other 510(k) Records For Product Code OLV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260585 | Noxturnal Web | Nox Medical Ehf | 2026-03-20 |
| K242447 | Falcon HST | Compumedics Limited | 2025-02-20 |
| K241288 | Noxturnal Web | Nox Medical Ehf | 2024-12-23 |
| K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | 2024-12-08 |
| K213007 | Cerebra Sleep System | Cerebra Medical , Ltd. | 2022-07-06 |
| K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020-08-12 |
| K192624 | ApneaTrak | Cadwell Industries, Inc. | 2020-02-20 |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. | 2018-11-16 |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. | 2018-07-02 |
| K173690 | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-09 |
| K172986 | Zmachine Synergy | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017-12-19 |
| K172711 | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017-11-03 |
| K161650 | Polysmith Sleep System, Model NTI7593 | Neurotronics, Inc. | 2017-01-19 |
| K142774 | Polysmith Sleep System | Neurotronics, Inc. | 2015-02-18 |
| K131415 | LIVE VIEW PANEL (LVP) | Neurotronics, Inc. | 2013-08-09 |
Legacy Summary#
summary
FDA Review#
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