Data / Medical devices / Norway / Laerdal Medical AS, Stavanger Manufacturing
Laerdal Medical AS, Stavanger Manufacturing: FDA-registered device maker in Sandnes Rogaland, Norway, 3 510(k) clearances
Laerdal Medical AS, Stavanger Manufacturing is registered with the FDA (registration 3031563234) in Sandnes Rogaland, Norway. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 25, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3031563234
- Address
- Vestre Svanholmen 3, Sandnes Rogaland, Norway, 4313
- Owner or operator
- LAERDAL MEDICAL A/S (9038993)
- Roles
- Manufacturer
- First device listed
- February 25, 2008
- Registered through
- 2026
- Brand names listed
- CPRmeter 2, Laerdal Suction Unit (LSU), NeoBeat, NeoBeat Mini
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Cardiopulmonary Resuscitation | LIX | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2024 | K232111 | NeoBeat, NeoBeat Mini | MWI | Substantially Equivalent | Laerdal Medical AS | accessdata.fda.gov |
| March 23, 2018 | K173886 | CPRmeter 2 CPR Feedback Device | LIX | Substantially Equivalent | Laerdal Medical AS | accessdata.fda.gov |
| December 20, 1999 | K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | BTA | Substantially Equivalent | Laerdal Medical A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Aid, Cardiopulmonary Resuscitation
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
Updated June 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.