The following data is part of a premarket notification filed by Non-invasive Monitoring Systems, Inc. with the FDA for Respitrace Plus, Respibands, And Respicentral.
| Device ID | K903011 |
| 510k Number | K903011 |
| Device Name: | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL |
| Classification | Monitor, Breathing Frequency |
| Applicant | NON-INVASIVE MONITORING SYSTEMS, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Contact | Rodney Munsey |
| Correspondent | Rodney Munsey NON-INVASIVE MONITORING SYSTEMS, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-09 |
| Decision Date | 1991-03-29 |