Proneb Turbo Compressor Model 38V0200
FDA 510(k) K962072 · Pari Holding Co.
510(k) numberK962072
Submission
- Device name
- Proneb Turbo Compressor Model 38V0200
- Applicant
- Pari Holding Co.
Richmond, VA, US - Received
- May 28, 1996
- Decision date
- August 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K002862 | Proneb Ultra Model Number 85B0100BTI · Traditional | 03/13/2001SE |
| K983308 | RC Cornet, Model #44F50BWF · Traditional | 06/04/1999SE |
| K972042 | Pari Pep Therapy SystemBWF · Traditional | 08/05/1997SE |
| K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70CAF · Traditional | 12/10/1996SE |
| K960675 | Walkhaler Portable Compressor Model 45F70CAF · Traditional | 05/17/1996SE |
| K935540 | Pari-Master ModificationCAF · Traditional | 03/17/1995SE |
| K944152 | Pari BabyCAF · Traditional | 11/18/1994SE |
Questions and answers
When was Proneb Turbo Compressor Model 38V0200 cleared by the FDA?
Proneb Turbo Compressor Model 38V0200 (K962072) received a 510(k) decision of Substantially Equivalent on August 21, 1996, 85 days after the submission was received.
What is the product code of K962072?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.