The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Amendment Lifepak 8, Npn 052.
| Device ID | K854117 |
| 510k Number | K854117 |
| Device Name: | AMENDMENT LIFEPAK 8, NPN 052 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Michael B Gropp |
| Correspondent | Michael B Gropp PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1986-01-13 |