The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepak 9 Defibrillator & Cardiac Monitor/modified.
| Device ID | K905510 |
| 510k Number | K905510 |
| Device Name: | LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | D Willingham |
| Correspondent | D Willingham PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1990-12-20 |