FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
BAROnova Insufflation System, BAROnova Accessory Kit
K Number: K190985
·
Decision May 14, 2019
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- BAROnova Insufflation System, BAROnova Accessory Kit
- K Number
- K190985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Baronova, Inc.
- Date Received
- April 15, 2019
- Decision Date
- May 14, 2019
- Product Code
- FCX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | FDA class 2 | Gastroenterology, Urology |
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