FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
K Number: K061902
·
Decision Dec 8, 2006
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
2
Review Days
156
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
- K Number
- K061902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inditherm Medical
- Date Received
- July 5, 2006
- Decision Date
- December 8, 2006
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWJ), ordered by most recent decision date.
Hot Pink Pad Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Warming System
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Temperature Management System (Model 5000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Celsi Warmer
FDA 510(k)
FDA Class 2
·Cardiovascular
Arctic Sun Stat Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
HotDog Warming Mattress + Return Electrode
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Inditherm Medical
| K Number | Device Name | ||
|---|---|---|---|
| K051419 | INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 | Apr 27, 2006 | Substantially Equivalent |