The following data is part of a premarket notification filed by Bib, Inc. with the FDA for Baro/trac Ii & Vita/trac, Vital Sign Mon.
Device ID | K801389 |
510k Number | K801389 |
Device Name: | BARO/TRAC II & VITA/TRAC, VITAL SIGN MON |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | BIB, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-13 |
Decision Date | 1980-07-28 |