FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH FLOW INSUFFLATION UNIT UHI-4
K Number: K110294
·
Decision Nov 18, 2011
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
174
Applicant Total
50
Review Days
290
Basic Information
- Device Name
- HIGH FLOW INSUFFLATION UNIT UHI-4
- K Number
- K110294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Date Received
- February 1, 2011
- Decision Date
- November 18, 2011
- Product Code
- HIF
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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