The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Shock Advisory Adapter For Use W/lifepak 9.
| Device ID | K892005 |
| 510k Number | K892005 |
| Device Name: | SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Sherri L Pocock |
| Correspondent | Sherri L Pocock PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-06-20 |