The following data is part of a premarket notification filed by Non-invasive Monitoring Systems, Inc. with the FDA for Respitrace Pt.
| Device ID | K942852 |
| 510k Number | K942852 |
| Device Name: | RESPITRACE PT |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | NON-INVASIVE MONITORING SYSTEMS, INC. 1300 NORTH 17TH STREET, SUITE 300 Arlington, VA 22209 |
| Contact | Marisa Coyle |
| Correspondent | Marisa Coyle NON-INVASIVE MONITORING SYSTEMS, INC. 1300 NORTH 17TH STREET, SUITE 300 Arlington, VA 22209 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-13 |
| Decision Date | 1996-02-13 |