The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Respitrace Plus.
| Device ID | K894973 |
| 510k Number | K894973 |
| Device Name: | RESPITRACE PLUS |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Rodney R Munsey |
| Correspondent | Rodney R Munsey HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1989-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RESPITRACE PLUS 74617697 1939947 Dead/Cancelled |
Non-Invasive Monitoring Systems, Inc. 1995-01-04 |