HIOX80 Aerosol Adapter
FDA 510(k) K032516 · Sensor Medics Corp.
510(k) numberK032516
Submission
- Device name
- HIOX80 Aerosol Adapter
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- August 14, 2003
- Decision date
- March 4, 2004
- 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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| K022192 | Pegasus Nasal CPAP SystemBZD · Traditional | 01/24/2003SE |
| K020665 | Hi-OxCBP · Traditional | 07/30/2002SE |
| K012085 | Somno Star & Series Sleep SystemOLV · Special | 08/02/2001SE |
| K012034 | Modification to: Sipap Infant Nasal CPAP CircuitBZD · Special | 07/24/2001SE |
| K991972 | Infant Flow SystemBZD · Special | 08/13/1999SE |
| K984254 | Infant Flow Ncpap MasksBZD · Traditional | 02/24/1999SE |
| K981366 | Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax SeriesBTY · Traditional | 10/30/1998SE |
Questions and answers
When was HIOX80 Aerosol Adapter cleared by the FDA?
HIOX80 Aerosol Adapter (K032516) received a 510(k) decision of Substantially Equivalent on March 4, 2004, 203 days after the submission was received.
What is the product code of K032516?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.