FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
K Number: K893653
·
Decision Jun 23, 1989
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
69
Review Days
39
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Basic Information
- Device Name
- RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
- K Number
- K893653
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Fischer Imaging Corp.
- Date Received
- May 15, 1989
- Decision Date
- June 23, 1989
- 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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|---|---|---|---|
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| K964806 | MD-1835 | Mar 4, 1997 | Substantially Equivalent |
| K961207 | EP-X BIPLANE | Aug 20, 1996 | Substantially Equivalent |
| K961022 | TANGENT VI TABLE | May 3, 1996 | Substantially Equivalent |
| K950291 | DIGITAL 625HF | Mar 23, 1995 | Substantially Equivalent |
| K945619 | ATHENA HFX | Mar 23, 1995 | Substantially Equivalent |
| K944147 | MICRO X-50 HF | Sep 16, 1994 | Substantially Equivalent |