The following data is part of a premarket notification filed by Respitrace Corp. with the FDA for Respitrace 300sc.
Device ID | K852692 |
510k Number | K852692 |
Device Name: | RESPITRACE 300SC |
Classification | Spirometer, Monitoring (w/wo Alarm) |
Applicant | RESPITRACE CORP. 731 SAW MILL RD. Ardsley, NY 10502 |
Contact | William Gruen |
Correspondent | William Gruen RESPITRACE CORP. 731 SAW MILL RD. Ardsley, NY 10502 |
Product Code | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-26 |
Decision Date | 1985-07-15 |