510(k) K141164
- Device
- ARTEMIS LIGHT ENGINE
- Applicant
- QUEST MEDICAL IMAGING
- 510(k) number
- K141164
- Product code
- NTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-16
- Date received
- 2014-05-05
- Regulation
- 876.1500
- Classification name
- Led Light Source
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN HEUVELMANS
- Address
- 526 S Main St. Akron OH US 44311 44311
FDA Registration Numbers#
- 1825146
- 3030516433
- 3041659934
- 9610617
- 3004443374
- 8010047
- 3003775006
- 3004837686
- 3036675345
- 3006161756
- 1057358
- 1000121056
- 3020746799
- 3011543740
- 3010399422
- 3012797688
- 3010707607
- 3042225166
- 9616693
- 3013440400
- 3004001706
- 9610773
- 2024311
- 3011050570
- 3009424883
- 3012322232
- 3015970743
- 3028058843
- 3012421607
- 3010273872
- 1820334
- 8043903
- 1418479
- 3030504644
- 3030535035
- 3016245408
- 1450019
- 3013002167
- 2085947
- 9610595
- 3011580044
- 3010202439
- 3007137643
- 3006345872
- 3008386005
- 1225687
- 3014644276
- 3013521677
- 3043152784
- 1828132
- 3014279513
- 2242464
- 1017294
- 9615782
- 9614434
- 3019512034
- 3007532396
- 3006546082
- 1218141
- 3029968414
- 3013247477
- 8010273
- 9611102
- 2020550
- 9681260
- 1320894
- 3015807001
- 3005099803
- 3011676349
- 3005216736
- 3014342096
- 3015612252
- 3019810045
- 3031563141
- 3001584149
- 3017555752
- 3002808148
- 3003018722
- 9681246
Source Documents#
Other 510(k) Records For Product Code NTN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133311 | ENDOLED | Olympus Winter & Ibe GmbH | 2014-07-30 |
| K130819 | CLL- V1 LIGHT SOURCE | Olympus Winter & Ibe GmbH | 2013-06-19 |
| K122831 | VIDEO SYSTEM CENTER | Olympus Medical Systems Corp. | 2012-12-14 |
| K113679 | LUCEA LED SURGICAL LIGHT SYSTEM | Maquet S.A.S. | 2012-01-12 |
| K103813 | SOPRO 281 | Sopro | 2011-03-22 |
| K102167 | LO-50 LED LIGHT SOURCE | Fiberoptics Technology, Inc. | 2010-08-17 |
| K091829 | PLS PORTABLE LIGHT SOURCE | Optim, Inc. | 2009-07-28 |
| K090601 | FSC 2 | Schoelly Imaging, Inc. | 2009-05-11 |
Legacy Summary#
summary
FDA Review#
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