FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CO2 LASER
K Number: K801197
·
Decision Jun 30, 1980
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
47
Applicant Total
4
Review Days
42
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Basic Information
- Device Name
- CO2 LASER
- K Number
- K801197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biomedical Instruments
- Date Received
- May 19, 1980
- Decision Date
- June 30, 1980
- Product Code
- HHR
- 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 |
|---|---|---|---|
| HHR | Laser, Surgical, Gynecologic | FDA class 2 | Obstetrics/Gynecology |
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