The following data is part of a premarket notification filed by Survivalink Corp. with the FDA for V2.
| Device ID | K970481 |
| 510k Number | K970481 |
| Device Name: | V2 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | SURVIVALINK CORP. 5420 FELTL RD. Minneapolis, MN 55343 |
| Contact | Sew-way Tay |
| Correspondent | Sew-way Tay SURVIVALINK CORP. 5420 FELTL RD. Minneapolis, MN 55343 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-07-01 |
| Summary: | summary |