The following data is part of a premarket notification filed by Laerdal Medical A/s with the FDA for Neonatalie Resuscitator.
| Device ID | K132172 |
| 510k Number | K132172 |
| Device Name: | NEONATALIE RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 Stavanger, NO N-4000 |
| Contact | Mari Kaada |
| Correspondent | Mari Kaada LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 Stavanger, NO N-4000 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2015-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045432091168 | K132172 | 000 |
| 07045432091151 | K132172 | 000 |
| 07045432066333 | K132172 | 000 |
| 07045432001938 | K132172 | 000 |
| 07045432001921 | K132172 | 000 |
| 07045432092042 | K132172 | 000 |