The following data is part of a premarket notification filed by Survivalink Corp. with the FDA for Firstsave Star Biphasic, Model 9210/9200.
| Device ID | K011901 |
| 510k Number | K011901 |
| Device Name: | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | SURVIVALINK CORP. 5420 FELTL RD. Minneapolis, MN 55343 |
| Contact | John Carline |
| Correspondent | John Carline SURVIVALINK CORP. 5420 FELTL RD. Minneapolis, MN 55343 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-18 |
| Decision Date | 2002-02-01 |
| Summary: | summary |