The following data is part of a premarket notification filed by Laerdal Medical A/s with the FDA for Cprmeter Cpr Feedback Device.
| Device ID | K122050 |
| 510k Number | K122050 |
| Device Name: | CPRMETER CPR FEEDBACK DEVICE |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | LAERDAL MEDICAL A/S 1 Geddes Way West Lafayette, IN 47906 |
| Contact | Dan Dillion |
| Correspondent | Dan Dillion LAERDAL MEDICAL A/S 1 Geddes Way West Lafayette, IN 47906 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-12 |
| Decision Date | 2012-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045432055290 | K122050 | 000 |