FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3002 AEROMAX
K Number: K942444
·
Decision Mar 10, 1995
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
19
Review Days
291
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
- 3002 AEROMAX
- K Number
- K942444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Industries America, Inc.
- Date Received
- May 23, 1994
- Decision Date
- March 10, 1995
- 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
Other Clearances by Medical Industries America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050990 | REMREST HEATED HUMIDIFIER | May 2, 2005 | Substantially Equivalent |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | May 28, 2004 | Substantially Equivalent |
| K002763 | REMREST | May 4, 2001 | Substantially Equivalent |
| K011053 | OPTIMA | Apr 20, 2001 | Substantially Equivalent |
| K964078 | 3050 SPORT-NEB | Jan 10, 1997 | Substantially Equivalent |
| K943990 | 3000 AEROSOL TWO | Mar 21, 1995 | Substantially Equivalent |
| K941961 | 605 VACU-MAX | Mar 2, 1995 | Substantially Equivalent |
| K942208 | 4003 AEROLITE | Feb 24, 1995 | Substantially Equivalent |
| K940630 | 503 MAXI COMPRESSOR | Feb 21, 1995 | Substantially Equivalent |
| K905593 | SLEEPAP | Apr 23, 1991 | Substantially Equivalent |