The following data is part of a premarket notification filed by Laerdal Medical As with the FDA for Reusable Silicone Cover Cprmeter 2.
| Device ID | K183348 |
| 510k Number | K183348 |
| Device Name: | Reusable Silicone Cover CPRmeter 2 |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | Laerdal Medical AS Tanke Svilandsgate 30 Stavanger, NO 2007 |
| Contact | Mari Kaada |
| Correspondent | Dan Dillon MED Institute Inc. 1330 Win Hentschel Blvd. West Lafayette, IN 47906 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2018-12-17 |
| Summary: | summary |