The following data is part of a premarket notification filed by Laerdal Medical As with the FDA for Cprmeter 2 Cpr Feedback Device.
Device ID | K173886 |
510k Number | K173886 |
Device Name: | CPRmeter 2 CPR Feedback Device |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-21 |
Decision Date | 2018-03-23 |
Summary: | summary |