Laerdal Mfg. Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Laerdal Mfg. Corp. makes
Laerdal Manufacturing Corporation produces defibrillation electrodes and automated external defibrillators (AEDs), including the HeartStart 1000, HeartStart 1000S, HeartStart 2000, and modified variants for defibrillation therapy. These devices are designed for emergency cardiac resuscitation, delivering electrical shocks to restore normal heart rhythm in cases of sudden cardiac arrest.
The company’s portfolio includes Class II and Class III medical devices, regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for defibrillation applications. The manufacturer operates from the United States.
Catalogue
Modified Heartstart Defibrillation Electrode Ref K902429
Regimes: 510(k) Registry: 510(k)Heartstart 2000 Defibrillation Electrode Ref K885186
Regimes: 510(k) Registry: 510(k)Heartstart 1000 Ref K883341
Regimes: 510(k) Registry: 510(k)Heartstart 1000S Ref K883344
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Laerdal Mfg. Corp. have in the registry?
The registry currently lists 5 devices for Laerdal Mfg. Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Laerdal Mfg. Corp.'s devices?
Among its 5 most recently registered devices, Laerdal Mfg. Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Laerdal Mfg. Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Laerdal Mfg. Corp.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Laerdal Mfg. Corp. in the registry?
The most recently registered devices listed for Laerdal Mfg. Corp. include MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE, HEARTSTART 2000 DEFIBRILLATION ELECTRODE, HEARTSTART 1000 and HEARTSTART 1000S.