The following data is part of a premarket notification filed by Survivalink Corp. with the FDA for Firstsave Biphasic Models 9200 And 9210.
| Device ID | K982264 |
| 510k Number | K982264 |
| Device Name: | FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | SURVIVALINK CORP. 5420 FELTL RD. Minneapolis, MN 55343 |
| Contact | Sew-wah Tay |
| Correspondent | Sew-wah Tay SURVIVALINK CORP. 5420 FELTL RD. Minneapolis, MN 55343 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1999-01-25 |
| Summary: | summary |