FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
K Number: DEN040009
·
Decision Nov 4, 2004
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
10
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
- K Number
- DEN040009
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 884.6200
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Hamilton Thorne Biosciences
- Date Received
- August 25, 2004
- Decision Date
- November 4, 2004
- Product Code
- MRX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MRX | System, Assisted Reproduction Laser | FDA class 2 | Obstetrics/Gynecology |
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