FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRANSWORLD 360V, MODEL A1-4040
K Number: K872357
·
Decision Jul 15, 1987
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- TRANSWORLD 360V, MODEL A1-4040
- K Number
- K872357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Transworld X-Ray Corp.
- Date Received
- June 18, 1987
- Decision Date
- July 15, 1987
- Product Code
- IZO
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Transworld X-Ray Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K892657 | SENSIMAT | Jun 23, 1989 | Substantially Equivalent |
| K890066 | STAR 36 | Mar 28, 1989 | Substantially Equivalent |
| K873283 | MODEL C2-5000 OVERHEAD TUBE SUPPORT | Sep 10, 1987 | Substantially Equivalent |
| K872980 | MAM-CP X-RAY APPARATUS | Aug 27, 1987 | Substantially Equivalent |
| K841923 | DCX-100 CHEST UNIT-GL-5000M | Aug 10, 1984 | Substantially Equivalent |
| K827582 | MODIFIED X-RAY TABLE | Jul 9, 1982 | Substantially Equivalent |