510(k) K905632
- Device
- NICOLET MAPLELEAF SYSTEM
- Applicant
- NICOLET INSTRUMENT CORP.
- 510(k) number
- K905632
- Product code
- GWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-06-07
- Date received
- 1990-12-17
- Regulation
- 882.1900
- Classification name
- Stimulator, Auditory, Evoked Response
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND RIDDLE
- Address
- 5225 Verona Rd. Madison WI US 53711 53711
FDA Registration Numbers#
- 9612330
- 9710602
- 3008857629
- 9613619
- 2080783
- 3034880867
- 3013596024
- 3013500228
- 8021990
- 3015781813
- 3013679558
- 3013501110
- 3010900508
- 3008111228
- 3010611950
- 1650946
- 3011310592
- 3012182497
- 1651104
- 3004046843
- 3000279201
- 3007048291
- 9612197
- 3007611554
- 3005581270
- 3005877899
- 3007962724
- 8030229
- 3004920696
- 3008483389
- 3010536822
- 3002504821
- 9611252
- 3016852448
- 3008729547
- 3006418479
- 3018094310
- 1052723
- 3009973505
- 2184161
- 3008881376
- 3038189172
- 3011184129
- 3001687738
- 9710051
- 9610105
- 2113281
- 3008773490
- 3016438694
- 3020018
- 1045254
- 3003851073
- 3004753785
- 3006177498
- 3009649442
- 2023374
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024-12-19 |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 |
| K220139 | QScreen | Path Medical GmbH | 2022-08-03 |
| K211147 | ALGO 7i | Path Medical GmbH | 2021-10-14 |
| K193033 | GSI Audera Pro | Grason Stadler | 2020-04-24 |
| K163326 | SmartEP | Intelligent Hearing Systems | 2017-09-29 |
| K162037 | Eclipse with VEMP | Interacoustics A/S | 2017-03-23 |
| K143670 | ICS CHARTR EP 200 WITH VEMP | Gn Otometrics A/S | 2015-10-23 |
| K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | Natus Medical Incorporated | 2014-08-22 |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | Gn Otometrics | 2014-02-27 |
| K131141 | EARPROBE | Path Medical GmbH | 2013-06-27 |
| K123701 | HEARLAB ACA | Frye Electronics, Inc. | 2013-04-05 |
| K122067 | TYPE 1077 ACCUSCREEN | Gn Otometrics | 2012-09-27 |
| K111555 | CIRCUMAURAL ADHESIVE REPLACEMENT | R & D Medical Products, Inc. | 2011-07-25 |
| K103760 | TITAN | Interacoustics A/S | 2011-05-05 |
Legacy Summary#
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FDA Review#
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