eRapid Nebulizer System
by Pari Respiratory Equipment, Inc. 2 variants
510(k) K223840
eRapid Nebulizer System is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K223840 on 11 Aug 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223840 | Date11 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K223840
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAF
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
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