3050 Sport-Neb
FDA 510(k) K964078 · Medical Industries America, Inc.
510(k) numberK964078
Submission
- Device name
- 3050 Sport-Neb
- Applicant
- Medical Industries America, Inc.
Adel, IA, US - Received
- October 11, 1996
- Decision date
- January 10, 1997
- 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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| K905593 | SleepapBZD · Traditional | 04/23/1991SE |
Questions and answers
When was 3050 Sport-Neb cleared by the FDA?
3050 Sport-Neb (K964078) received a 510(k) decision of Substantially Equivalent on January 10, 1997, 91 days after the submission was received.
What is the product code of K964078?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.