The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Truecpr Coaching Device.
| Device ID | K123597 |
| 510k Number | K123597 |
| Device Name: | TRUECPR COACHING DEVICE |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Teresa Davidson |
| Correspondent | Teresa Davidson PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-04-17 |
| Summary: | summary |