FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K Number: K023434
·
Decision Nov 14, 2002
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
- K Number
- K023434
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 884.2980
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dorex, Inc.
- Date Received
- October 15, 2002
- Decision Date
- November 14, 2002
- Product Code
- LHQ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | FDA class 1 | Obstetrics/Gynecology |
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Other Clearances by Dorex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812799 | DCATS | Oct 20, 1981 | Substantially Equivalent |