The following data is part of a premarket notification filed by Respitrace Corp. with the FDA for Respitrace 300sc.
| Device ID | K823780 |
| 510k Number | K823780 |
| 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 | 1982-12-15 |
| Decision Date | 1984-01-20 |