RC Cornet, Model #44F50
FDA 510(k) K983308 · Pari Holding Co.
510(k) numberK983308
Submission
- Device name
- RC Cornet, Model #44F50
- Applicant
- Pari Holding Co.
Midlothian, VA, US - Received
- September 21, 1998
- Decision date
- June 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70CAF · Traditional | 12/10/1996SE |
| K962072 | Proneb Turbo Compressor Model 38V0200CAF · Traditional | 08/21/1996SE |
| 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 RC Cornet, Model #44F50 cleared by the FDA?
RC Cornet, Model #44F50 (K983308) received a 510(k) decision of Substantially Equivalent on June 4, 1999, 256 days after the submission was received.
What is the product code of K983308?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.