The following data is part of a premarket notification filed by Non-invasive Monitoring Systems, Inc. with the FDA for Respitrak.
| Device ID | K884959 |
| 510k Number | K884959 |
| Device Name: | RESPITRAK |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | NON-INVASIVE MONITORING SYSTEMS, INC. DICKSTEIN, SHAPIRO & MORIN 2101 L STREET, N.W. Washington, DC 20037 |
| Contact | Rodney R Munsey |
| Correspondent | Rodney R Munsey NON-INVASIVE MONITORING SYSTEMS, INC. DICKSTEIN, SHAPIRO & MORIN 2101 L STREET, N.W. Washington, 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 | 1988-11-29 |
| Decision Date | 1989-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RESPITRAK 74161830 1717840 Dead/Cancelled |
Non-Invasive Monitoring Systems, Inc. 1991-04-29 |