The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Pediatric Disposable External Defibrilation/ecg.
| Device ID | K912966 |
| 510k Number | K912966 |
| Device Name: | PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG |
| 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 | 1991-07-08 |
| Decision Date | 1992-02-21 |