FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COSMOS
K Number: K870856
·
Decision Mar 30, 1987
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
8
Review Days
27
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Basic Information
- Device Name
- COSMOS
- K Number
- K870856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Pausch Corp.
- Date Received
- March 3, 1987
- Decision Date
- March 30, 1987
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Pausch Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Jun 17, 1998 | Substantially Equivalent |
| K973834 | CS2000 & CS2000 TOMO | Apr 30, 1998 | Substantially Equivalent |
| K903395 | UROMAT 2000 | Aug 30, 1990 | Substantially Equivalent |
| K790742 | KS-78 VERTICAL WALL CASSETTE HOLDER | Apr 26, 1979 | Substantially Equivalent |
| K790740 | BS 66, UNIVERSAL BUCKY STAND | Apr 26, 1979 | Substantially Equivalent |
| K790741 | COMPACT SYSTEM | Apr 26, 1979 | Substantially Equivalent |
| K790743 | COORDINATUS, HORIZONTAL RADIOGRAPHOC | Apr 23, 1979 | Substantially Equivalent |