FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JANUS ATAC ENG ANALYSIS SYSTEM
K Number: K904385
·
Decision Jun 10, 1992
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
58
Applicant Total
68
Review Days
625
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Basic Information
- Device Name
- JANUS ATAC ENG ANALYSIS SYSTEM
- K Number
- K904385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- September 24, 1990
- Decision Date
- June 10, 1992
- Product Code
- GWN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWN | Nystagmograph | FDA class 2 | Neurology |
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|---|---|---|---|
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| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |