FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID THERMAL EXCHANGE SYSTEM
K Number: K023934
·
Decision Jan 23, 2003
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
2
Review Days
58
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Basic Information
- Device Name
- RAPID THERMAL EXCHANGE SYSTEM
- K Number
- K023934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avacore Technologies, Inc.
- Date Received
- November 26, 2002
- Decision Date
- January 23, 2003
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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 |
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Other Clearances by Avacore Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K014210 | PALMO THERMOREGULATION INTERFACE ACCESSORY | Aug 16, 2002 | Substantially Equivalent |