510(k) K983406
- Device
- SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
- Applicant
- BANTA HEALTHCARE GROUP, LTD.
- 510(k) number
- K983406
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-10-19
- Date received
- 1998-09-28
- 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
- RICHARD PEPPARD
- Address
- 570 Enterprise Dr. P.O. Box 806 Neenah WI US 54957 54957
FDA Registration Numbers#
- 3008717264
- 3010852191
- 3038610665
- 3007703436
- 3000206696
- 3003263092
- 3032916632
- 3000130829
- 3013496867
- 3030626857
- 3007748817
- 1915484
- 3010419931
- 3008058135
- 3015997711
- 2081040
- 3011182134
- 3013874291
- 2381321
- 3003887292
- 3012840029
- 3024512705
- 3014579161
- 1250045
- 3008048783
- 3005031124
- 2184009
- 3009328501
- 3019470217
- 3004009431
- 1000137876
- 3015134004
- 1217805
- 3035111606
- 1060680
- 3043226252
- 3006979678
- 3005798905
- 3013019728
- 1018233
- 3030089838
- 3013826848
- 3005841768
- 3027285900
- 3043479346
- 1832894
- 3026032283
- 3003971136
- 3005569927
- 3013426279
- 3012302888
- 1721686
- 3005621440
- 1055236
- 1450057
- 3021635975
- 3012312061
- 3024999438
- 9617604
- 8043685
- 3012416077
- 3008879776
- 3010288146
- 3008011951
- 3036108847
- 2434115
- 3009437315
- 3005613467
- 1220908
- 3031841433
- 9610105
- 1216677
- 3012494290
- 3003993690
- 3034603279
- 3024790242
- 3030597679
- 3009540516
- 3009617411
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases