FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
BREAST & BODY HEALTH SYSTEM 2000
K Number: K832731
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
2
Review Days
179
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Basic Information
- Device Name
- BREAST & BODY HEALTH SYSTEM 2000
- K Number
- K832731
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 884.2982
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- American Thermal Instruments, Inc.
- Date Received
- August 4, 1983
- Decision Date
- January 30, 1984
- Product Code
- KXZ
- 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 |
|---|---|---|---|
| KXZ | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) | FDA class 3 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXZ), ordered by most recent decision date.
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Other Clearances by American Thermal Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832651 | ATI FOREHEAD THERMOMETER | Oct 4, 1983 | Substantially Equivalent |