The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Sterilizable Internal Defibrillation Paddles For Use With Lifepak Defibrillators/monitors.
| Device ID | K182503 |
| 510k Number | K182503 |
| Device Name: | Sterilizable Internal Defibrillation Paddles For Use With LIFEPAK Defibrillators/monitors |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | Physio-Control, Inc. 11811 Willow Road NE Redmond, WA 98052 |
| Contact | Chelsea Cullen |
| Correspondent | Chelsea Cullen Physio-Control, Inc. 11811 Willow Road NE Redmond, WA 98052 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883873863558 | K182503 | 000 |
| 00883873863534 | K182503 | 000 |
| 00883873863527 | K182503 | 000 |
| 00883873863510 | K182503 | 000 |
| 00883873863503 | K182503 | 000 |
| 00883873863497 | K182503 | 000 |
| 00883873863480 | K182503 | 000 |
| 00883873863213 | K182503 | 000 |