The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Personal Defibrillator.
| Device ID | K832833 |
| 510k Number | K832833 |
| Device Name: | PERSONAL DEFIBRILLATOR |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98052 |
| Contact | Sylvia Lemke |
| Correspondent | Sylvia Lemke PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98052 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1984-10-26 |