The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Non-invasive Clinical Vascular Lab.
Device ID | K832679 |
510k Number | K832679 |
Device Name: | NON-INVASIVE CLINICAL VASCULAR LAB |
Classification | Phonocardiograph |
Applicant | LIFE SCIENCES MANUFACTURING, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQC |
CFR Regulation Number | 870.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-09 |
Decision Date | 1984-01-03 |