FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRAMEWAVE WEB
K Number: K983401
·
Decision Dec 15, 1998
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
4
Review Days
78
Basic Information
- Device Name
- FRAMEWAVE WEB
- K Number
- K983401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ML STRATEGIES, INC.
- Date Received
- September 28, 1998
- Decision Date
- December 15, 1998
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K973363 | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 | Jul 2, 1998 | Substantially Equivalent |
| K972271 | NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A | Oct 28, 1997 | Substantially Equivalent |
| K950354 | HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY | Jul 19, 1995 | Substantially Equivalent |