FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMAX; THERMAX SYSTEM
K Number: K823245
·
Decision Nov 16, 1982
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
3
Review Days
15
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Basic Information
- Device Name
- THERMAX; THERMAX SYSTEM
- K Number
- K823245
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.2982
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- American Thermometer Company, Inc.
- Date Received
- November 1, 1982
- Decision Date
- November 16, 1982
- Product Code
- KYA
- 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 |
|---|---|---|---|
| KYA | System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) | FDA class 1 | Obstetrics/Gynecology |
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