FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALILEO HIGH RESOLUTION MICRO COUPLER
K Number: K971896
·
Decision Oct 10, 1997
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
4
Review Days
141
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Basic Information
- Device Name
- GALILEO HIGH RESOLUTION MICRO COUPLER
- K Number
- K971896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Netoptix Corp.
- Date Received
- May 22, 1997
- Decision Date
- October 10, 1997
- Product Code
- HET
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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