FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUAL PHOTON BONE DENSITOMETER
K Number: K861233
·
Decision Mar 3, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
5
Review Days
336
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Basic Information
- Device Name
- DUAL PHOTON BONE DENSITOMETER
- K Number
- K861233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medical and Scientific Enterprises, Inc.
- Date Received
- April 1, 1986
- Decision Date
- March 3, 1987
- Product Code
- KGI
- 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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Other Clearances by Medical and Scientific Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933131 | BISTAT 70/70-I ELECTROSURGICAL UNIT | Feb 15, 1994 | Substantially Equivalent |
| K913881 | ENDOSTAT ELECTROSURGICAL UNIT | Nov 1, 1991 | Substantially Equivalent |
| K895855 | PHOENIX | Jan 22, 1990 | Substantially Equivalent |
| K882453 | POLYSCAN DIGITAL SCANNER | Nov 23, 1988 | Substantially Equivalent |