FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOGRAM BONE DENSITOMETER
K Number: K984285
·
Decision May 19, 1999
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
6
Review Days
169
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Basic Information
- Device Name
- OSTEOGRAM BONE DENSITOMETER
- K Number
- K984285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compumed, Inc.
- Date Received
- December 1, 1998
- Decision Date
- May 19, 1999
- 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 Compumed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955708 | COMPUMED DICON CLIENT | Mar 1, 1996 | Substantially Equivalent |
| K863965 | KENZ-ECG 102 | Dec 22, 1986 | Substantially Equivalent |
| K854626 | COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B | Feb 28, 1986 | Substantially Equivalent |
| K802272 | COMPUTER ECG TERMINAL | Sep 26, 1980 | Substantially Equivalent |
| K771648 | COMPUTER ECG TERMINAL | Sep 20, 1977 | Substantially Equivalent |