FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRALITE BACKPOINTER
K Number: K893398
·
Decision Aug 17, 1989
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
27
Applicant Total
10
Review Days
108
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Basic Information
- Device Name
- CENTRALITE BACKPOINTER
- K Number
- K893398
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Diacor, Inc.
- Date Received
- May 1, 1989
- Decision Date
- August 17, 1989
- Product Code
- IWE
- 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 |
|---|---|---|---|
| IWE | Monitor, Patient Position, Light-Beam | FDA class 1 | Radiology |
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Other Clearances by Diacor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K050888 | INTEGRA IMMOBILIZATION SYSTEM | May 23, 2005 | Substantially Equivalent |
| K954414 | CENTRALITE BACKPOINTER | Oct 23, 1995 | Substantially Equivalent |
| K953046 | PERI-PUSHER | Sep 22, 1995 | Substantially Equivalent |
| K950112 | CENTRALITE(R)-DLL SERIES | Aug 16, 1995 | Substantially Equivalent |
| K934566 | RADASSIST | Nov 3, 1993 | Substantially Equivalent |
| K930246 | MAMMORX | Jul 26, 1993 | Substantially Equivalent |
| K872489 | CENTRALITE | Jul 15, 1987 | Substantially Equivalent |
| K860193 | PORTALCAST | Jan 30, 1986 | Substantially Equivalent |