FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLLIMATOR LIGHT SOURCE
K Number: K924759
·
Decision Dec 9, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- COLLIMATOR LIGHT SOURCE
- K Number
- K924759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Denar Corp.
- Date Received
- September 23, 1992
- Decision Date
- December 9, 1992
- Product Code
- IZT
- 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 |
|---|---|---|---|
| IZT | Cone, Radiographic | FDA class 2 | Radiology |
Other Clearances by Denar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K925705 | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | Dec 28, 1992 | Substantially Equivalent |
| K884845 | STERI-OSS | Feb 10, 1989 | Substantially Equivalent |
| K883373 | STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT | Jan 13, 1989 | Substantially Equivalent |
| K852802 | DENAR DENTAL IMPLANT | Sep 23, 1985 | Substantially Equivalent |