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 |