RESPIGRAPH
Spirometer, Monitoring (w/wo Alarm)
RESPITRACE CORP.
The following data is part of a premarket notification filed by Respitrace Corp. with the FDA for Respigraph.
Pre-market Notification Details
| Device ID | K854956 |
| 510k Number | K854956 |
| Device Name: | RESPIGRAPH |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | RESPITRACE CORP. C/O DICKSTEIN, SHAPIRO & MORIN 2101 L STREET, N.W. Washingtn, DC 20037 |
| Contact | Rodney R Munsey |
| Correspondent | Rodney R Munsey RESPITRACE CORP. C/O DICKSTEIN, SHAPIRO & MORIN 2101 L STREET, N.W. Washingtn, DC 20037 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-11 |
| Decision Date | 1986-03-20 |
Trademark Results [RESPIGRAPH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESPIGRAPH 73573932 1434603 Dead/Cancelled |
RESPITRACE CORPORATION 1985-12-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.