FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIBEROPTIC HEADLIGHT SYSTEM
K Number: K893458
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
9
Applicant Total
17
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FIBEROPTIC HEADLIGHT SYSTEM
- K Number
- K893458
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Cuda Products Co.
- Date Received
- May 2, 1989
- Decision Date
- June 22, 1989
- Product Code
- EBA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EBA | Light, Surgical Headlight | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBA), ordered by most recent decision date.
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
FDA 510(k)
FDA Class 1
·Dental
SYLVAN DENTAL HEADLIGHT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
VEGA DENTAL OPERATING LIGHT
FDA 510(k)
FDA Class 1
·Dental
SURGICAL HEADLIGHT
FDA 510(k)
FDA Class 1
·Dental
ISOLIGHT
FDA 510(k)
FDA Class 1
·Dental
FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Cuda Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Dec 16, 1998 | Substantially Equivalent |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Aug 18, 1998 | Substantially Equivalent |
| K981469 | CERMAX300 LIGHTSOURCE | Jul 9, 1998 | Substantially Equivalent |
| K980350 | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 | Apr 28, 1998 | Substantially Equivalent |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | Apr 1, 1998 | Substantially Equivalent |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Apr 30, 1996 | Substantially Equivalent |
| K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | May 10, 1995 | Substantially Equivalent |
| K943731 | VIDEO OTOSCOPE | Oct 11, 1994 | Substantially Equivalent |
| K935818 | ENDOSCOPE | Jul 13, 1994 | Substantially Equivalent |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Jan 3, 1994 | Substantially Equivalent |