The following data is part of a premarket notification filed by Heartstream, Inc. with the FDA for Fore Runner External Defibrillator/defibrillator Pads.
| Device ID | K955628 |
| 510k Number | K955628 |
| Device Name: | FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 Seattle, WA 98121 |
| Contact | Lori Glastetter |
| Correspondent | Lori Glastetter HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 Seattle, WA 98121 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838029569 | K955628 | 000 |
| 00884838023710 | K955628 | 000 |
| 00884838023727 | K955628 | 000 |