510(k) K152748
- Device
- Braun Thermoscan PRO 6000 Ear Thermometer
- Applicant
- KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC)
- 510(k) number
- K152748
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-01
- Date received
- 2015-09-23
- Regulation
- 880.2910
- Classification name
- Thermometer, Electronic, Clinical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAJ KASBEKAR
- Address
- 250 Tpke. Rd. Southborough MA US 01772 01772
FDA Registration Numbers#
- 9615817
- 3024790242
- 3013689228
- 3033530347
- 3010405299
- 1422443
- 3008507279
- 1060680
- 3006845687
- 3013500228
- 3008771621
- 3014848734
- 3008048783
- 3008754120
- 3010041511
- 3012251275
- 9710548
- 3026264
- 3011792045
- 9613793
- 3021422553
- 3010713600
- 3023272766
- 3012359877
- 2030624
- 1055808
- 3034405508
- 8010026
- 3021559257
- 3007603826
- 1723241
- 3003630387
- 3010968402
- 3043668257
- 3003971136
- 3013426279
- 3012316249
- 3003965134
- 3018783553
- 3008058135
- 3005951243
- 3003993690
- 3029871637
- 3016509757
- 3028019184
- 3011191255
- 3032109181
- 3021186226
- 3006852457
- 3004415095
- 3017422354
- 3037007069
- 3011713222
- 3015058854
- 3010476117
- 1000137876
- 1419898
- 3009617411
- 3032948391
- 2111760
- 3004832480
- 1832894
- 9680961
- 3011065399
- 3013557562
- 3006636961
- 3007413079
- 3005783425
- 3007137643
- 3007499349
- 1417592
- 3010157426
- 3009831876
- 3005583357
- 3020848330
- 3006176286
- 1066270
- 3012312061
- 9681834
Source Documents#
Other 510(k) Records For Product Code FLL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 |
| K250401 | AION TempShield™ | Aion Biosystems, Inc. | 2025-03-14 |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | 2025-02-14 |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 |
| K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | 2024-08-20 |
| K233280 | SteadyTemp | Steadysense GmbH | 2024-06-21 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | 2024-04-05 |
Legacy Summary#
summary
FDA Review#
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