FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
K Number: K130598
·
Decision Jun 5, 2013
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
15
Applicant Total
1
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
- K Number
- K130598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inspirx, Inc.
- Date Received
- March 7, 2013
- Decision Date
- June 5, 2013
- Product Code
- NVP
- 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 |
|---|---|---|---|
| NVP | Holding Chambers, Direct Patient Interface | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NVP), ordered by most recent decision date.
AeroChamber2go Anti-Static Valved Holding Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
FDA 510(k)
FDA Class 2
·Anesthesiology
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
Antistatic Compact Space Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology