FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROVENT NASAL CANNULA
K Number: K080983
·
Decision Aug 7, 2008
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
5
Review Days
122
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Basic Information
- Device Name
- PROVENT NASAL CANNULA
- K Number
- K080983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ventus Medical, Inc.
- Date Received
- April 7, 2008
- Decision Date
- August 7, 2008
- Product Code
- MNR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K120665 | INVENT SNORING DEVICE | Jun 12, 2012 | Substantially Equivalent |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | Dec 2, 2010 | Substantially Equivalent |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | Apr 3, 2009 | Substantially Equivalent |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | Feb 8, 2008 | Substantially Equivalent |