VIANOX DELIVERY SYSTEM, MODEL I
FDA 510(k) clearance K023014 · decided 2003-08-14
Clearance details
- K-number
- K023014
- Device name
- VIANOX DELIVERY SYSTEM, MODEL I
- Applicant
- Pulmonox Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-10
- Decision date
- 2003-08-14
- Days to decision
- 338 days
- Clearance type
- Traditional
- Product code
- MRP
- Device class
- 2
- Regulation number
- 868.2380
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Edmonton, Ab, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pulmonox Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.