The following data is part of a premarket notification filed by Respitrace Corp. with the FDA for Respitrace.
Device ID | K772016 |
510k Number | K772016 |
Device Name: | RESPITRACE |
Classification | Spirometer, Monitoring (w/wo Alarm) |
Applicant | RESPITRACE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-25 |
Decision Date | 1978-01-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RESPITRACE 73300932 1184587 Live/Registered |
Respitrace Corporation 1981-03-13 |