510(k) K030580
- Device
- SURETEMP PLUS
- Applicant
- WELCH ALLYN, INC.
- 510(k) number
- K030580
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-06
- Date received
- 2003-02-24
- 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
- DEBRA L JACKSON
- Address
- 7420 Carroll Rd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3010097171
- 3003587684
- 8022257
- 3013689228
- 3000215556
- 3003832357
- 3011862780
- 3010521050
- 3015140207
- 3002736372
- 2182979
- 3037007069
- 3008559238
- 1832894
- 1723241
- 3007048291
- 1036863
- 3004111573
- 3014468707
- 3011654863
- 3012528160
- 3012933969
- 9680961
- 3007307487
- 3005699784
- 3008717264
- 1450758
- 3017887928
- 3016595211
- 3004871905
- 3014886121
- 3016693518
- 3005783425
- 2518422
- 3044754336
- 3003622639
- 3013481815
- 3006845687
- 3006845683
- 3033715634
- 3011898560
- 3016088707
- 3027510187
- 3013500228
- 3014579161
- 3027344406
- 3010041511
- 3008058135
- 1422443
- 9681834
- 1835242
- 3012678246
- 3007137643
- 1055808
- 3003399181
- 9613793
- 1718850
- 3007703436
- 3009327812
- 3015188281
- 3011792045
- 3005798905
- 2030624
- 3030597679
- 1055236
- 1928237
- 3015422337
- 9681384
- 3016864576
- 3032916632
- 3005877899
- 3009756153
- 3007407626
- 3004835896
- 3007499349
- 1423537
- 3006176286
- 3010370454
- 3013679558
- 3006142663
Source Documents#
Other 510(k) Records For Product Code FLL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | 2026-06-05 |
| 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 |
Legacy Summary#
summary
FDA Review#
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