FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
K Number: K990919
·
Decision Apr 15, 1999
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
28
Basic Information
- Device Name
- STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
- K Number
- K990919
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VISUALIZATION TECHNOLOGY, INC.
- Date Received
- March 18, 1999
- Decision Date
- April 15, 1999
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by VISUALIZATION TECHNOLOGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K003510 | INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 | Feb 12, 2001 | Substantially Equivalent |
| K994270 | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 | Mar 9, 2000 | Substantially Equivalent |
| K983529 | INSTATRAK 3000 | Dec 31, 1998 | Substantially Equivalent |
| K982994 | SKULL BASE INSTATRAK SYSTEM | Nov 16, 1998 | Substantially Equivalent |
| K981998 | PEDIATRIC INSTATRAK SYSTEM | Aug 21, 1998 | Substantially Equivalent |
| K960330 | INSTATRAK | Apr 8, 1996 | Substantially Equivalent |