The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Heartstart 911.
| Device ID | K954609 |
| 510k Number | K954609 |
| Device Name: | HEARTSTART 911 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | LAERDAL MEDICAL CORP. 167 MYERS CORNERS RD. Wappingers Falls, NY 12590 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B Herland LAERDAL MEDICAL CORP. 167 MYERS CORNERS RD. Wappingers Falls, NY 12590 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-04 |
| Decision Date | 1996-01-04 |