The following data is part of a premarket notification filed by Mirador Biomedical, Inc. with the FDA for Compass Vascular Access; Compass Lumbar Puncture.
Device ID | K101518 |
510k Number | K101518 |
Device Name: | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle, WA 98102 |
Contact | Justin Hulvershorn Md, Phd |
Correspondent | Justin Hulvershorn Md, Phd MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle, WA 98102 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-02 |
Decision Date | 2010-10-13 |
Summary: | summary |