510(k) K242964
- Device
- Celsi Warmer
- Applicant
- Hadleigh Health Technologies
- 510(k) number
- K242964
- Product code
- DWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-20
- Date received
- 2024-09-26
- Regulation
- 870.5900
- Classification name
- System, Thermal Regulating
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Molly McCabe
- Address
- 200 Gate Five Rd., Suite 215 Sausalito CA US 94965 94965
FDA Registration Numbers
- 9617473
- 1220351
- 3004362278
- 3008879776
- 1043644
- 3010617000
- 2133786
- 1722070
- 2530138
- 3011059079
- 2183744
- 1066427
- 3013188547
- 3012972101
- 3021073836
- 3008352384
- 1219702
- 8022590
- 3013557562
- 3010168054
- 9614306
- 3008727520
- 3012307300
- 3005857264
- 3032911850
- 1018233
- 1725056
- 9611590
- 3010476117
- 1043214
- 3012315097
- 1055236
- 3012421607
- 1000484830
- 3013410562
- 3007309299
- 2029015
- 3014263632
- 3042272797
- 3004491421
- 3007616088
- 2936999
- 1417592
- 3003542872
- 3031841433
- 9680284
- 3013041594
- 2133641
- 3010317211
- 3012689738
- 3014426939
- 3003857828
- 3005941719
- 3012494290
- 3034393266
- 2320762
- 2432320
- 2032112
- 3029871637
- 2133810
- 1055823
- 3036108847
- 3005238200
- 3009093866
- 3004986960
- 3035108304
- 3041276890
- 1060680
- 3030597679
- 3014421917
- 1043572
- 9610849
- 1054241
- 3016844398
- 3016507522
- 1836518
- 3043226252
- 3009746061
- 3009609358
- 9616567
- 3005997949
- 3010380518
- 9616096
- 2011171
- 2183613
- 9617604
- 3006240053
- 3018094310
- 1516825
- 1000122786
- 3038241934
Source Documents
Other 510(k) Records For Product Code DWJ
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|---|---|---|---|
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | 2026-04-16 |
| K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 |
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | 2025-10-24 |
| K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2025-04-30 |
| K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2024-04-18 |
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024-02-21 |
| K231211 | Medline ComfortTemp Patient Warming System | Medline Industries, LP | 2023-12-01 |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023-10-24 |
| K232844 | The IQoolTM System | Braincool AB | 2023-10-04 |
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | 2023-09-15 |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023-06-30 |
| K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023-06-29 |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022-12-27 |
| K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022-09-23 |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | 2021-04-29 |