The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for 12-lead Ecg Adaptor For Use W/lifepak 10 Defib/mon.
| Device ID | K910144 |
| 510k Number | K910144 |
| Device Name: | 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON |
| 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 | 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 | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-07-17 |