Proneb Max
by Pari Respiratory Equipment, Inc.
510(k) K191270
Proneb Max 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) K191270 on 23 Jan 2020, 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 | NumberK191270 | Date23 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K191270
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- Withdrawn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
Devices cleared under K191270
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Proneb Max 130F1002 | 130F1002 | 00744229130062 | On the market | |
| Proneb Max 130F1002P12 | 130F1002P12 | 00744229130055 | On the market | |
| Proneb Max 130F1002P2 | na / 130F1002P2 | 00744229130048 | On the market | |
| Proneb Max 130F35-LCS | na / 130F35-LCS | 00744229130017 | On the market | |
| Proneb Max 130F83-LC+ | na / 130F83-LC+ | 00744229130024 | On the market |
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Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
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