FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
K Number: K091794
·
Decision Jan 28, 2010
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
1
Review Days
225
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
- CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
- K Number
- K091794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steve Islava
- Date Received
- June 17, 2009
- Decision Date
- January 28, 2010
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAF), ordered by most recent decision date.
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
FDA 510(k)
FDA Class 2
·Anesthesiology
eRapid with eTrack System
FDA 510(k)
FDA Class 2
·Anesthesiology
Mesh Nebulizer (H6)
FDA 510(k)
FDA Class 2
·Anesthesiology
Portable mesh nebulizer (JM821)
FDA 510(k)
FDA Class 2
·Anesthesiology
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
FDA 510(k)
FDA Class 2
·Anesthesiology
HeroTracker Sense
FDA 510(k)
FDA Class 2
·Anesthesiology