FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3000 AEROSOL TWO
K Number: K943990
·
Decision Mar 21, 1995
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
19
Review Days
217
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Basic Information
- Device Name
- 3000 AEROSOL TWO
- K Number
- K943990
- 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
- August 16, 1994
- Decision Date
- March 21, 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 |
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|---|---|---|---|
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| K011053 | OPTIMA | Apr 20, 2001 | Substantially Equivalent |
| K964078 | 3050 SPORT-NEB | Jan 10, 1997 | Substantially Equivalent |
| K942444 | 3002 AEROMAX | Mar 10, 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 |