Transneb Compressor W/Nebulizer, Model 5000
FDA 510(k) K032170 · Medical Industries America, Inc.
510(k) numberK032170
Submission
- Device name
- Transneb Compressor W/Nebulizer, Model 5000
- Applicant
- Medical Industries America, Inc.
Adel, IA, US - Received
- July 16, 2003
- Decision date
- May 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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Questions and answers
When was Transneb Compressor W/Nebulizer, Model 5000 cleared by the FDA?
Transneb Compressor W/Nebulizer, Model 5000 (K032170) received a 510(k) decision of Substantially Equivalent on May 28, 2004, 317 days after the submission was received.
What is the product code of K032170?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.