The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Heartstart 3000.
| Device ID | K896919 |
| 510k Number | K896919 |
| Device Name: | HEARTSTART 3000 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | LAERDAL MEDICAL CORP. 12244 S.W. GARDEN PLACE Portland, OR 97223 |
| Contact | John Karpowicz |
| Correspondent | John Karpowicz LAERDAL MEDICAL CORP. 12244 S.W. GARDEN PLACE Portland, OR 97223 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-12 |
| Decision Date | 1990-05-03 |