4003 Aerolite
FDA 510(k) K942208 · Medical Industries America, Inc.
510(k) numberK942208
Submission
- Device name
- 4003 Aerolite
- Applicant
- Medical Industries America, Inc.
Adel, IA, US - Received
- May 5, 1994
- Decision date
- February 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| 510(k) | Device | Decision |
|---|---|---|
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| K002763 | RemrestBZD · Traditional | 05/04/2001SE |
| K011053 | OptimaITI · Traditional | 04/20/2001SE |
| K964078 | 3050 Sport-NebCAF · Traditional | 01/10/1997SE |
| K943990 | 3000 Aerosol TwoCAF · Traditional | 03/21/1995SE |
| K942444 | 3002 AeromaxCAF · Traditional | 03/10/1995SE |
| K941961 | 605 Vacu-MaxBTA · Traditional | 03/02/1995SE |
| K940630 | 503 Maxi CompressorBTI · Traditional | 02/21/1995SE |
| K905593 | SleepapBZD · Traditional | 04/23/1991SE |
Questions and answers
When was 4003 Aerolite cleared by the FDA?
4003 Aerolite (K942208) received a 510(k) decision of Substantially Equivalent on February 24, 1995, 295 days after the submission was received.
What is the product code of K942208?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.