FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRUE VISION, TRUE VISION II
K Number: K974542
·
Decision Feb 17, 1998
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
18
Review Days
76
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Basic Information
- Device Name
- TRUE VISION, TRUE VISION II
- K Number
- K974542
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Dynamics, Inc.
- Date Received
- December 3, 1997
- Decision Date
- February 17, 1998
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Medical Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921294 | VIDEO ENDOSCOPE-RIGID MODIFICATION | Jul 20, 1994 | Substantially Equivalent |
| K934682 | SURGICAL VIDEO CAMERA AND ACCESSORIES | Feb 15, 1994 | Substantially Equivalent |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | Jul 22, 1993 | Substantially Equivalent |
| K915538 | OVER THE WIRE STONE BASKET | Mar 20, 1992 | Substantially Equivalent |
| K914315 | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION | Mar 4, 1992 | Substantially Equivalent |
| K913986 | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM | Jan 28, 1992 | Unknown |
| K911296 | OPTICAL CATHETER ARTHROSCOPE | Sep 24, 1991 | Substantially Equivalent |
| K903339 | VIDEO ENDOSCOPE, RIGID | Mar 6, 1991 | Substantially Equivalent |
| K904609 | XENON LIGHT SOURCE | Dec 18, 1990 | Substantially Equivalent |
| K904113 | OPERATIVE RECORDING CAMERA | Oct 30, 1990 | Substantially Equivalent |