Embletta Mpr
510(k) K122516
Embletta Mpr is a medical device (FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Embla Systems, cleared under FDA 510(k) K122516 on 21 Feb 2013, 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 | NumberK122516 | Date21 Feb 2013 | StatusActive |
Official records
- FDA 510(k) database K122516
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNR
- Device class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K122516
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 | |||
|---|---|---|---|---|
| Natus 011782 | 011782 | 00382830059244 | — | On the market |
| Xltek 011291 | 011291 | 00382830024662 | — | On the market |
| Xltek 1411542 | 1411542 | 00382830027434 | — | On the market |
| Xltek 2013030 | 2013030 | 00382830023849 | — | On the market |
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Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).
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