The following data is part of a premarket notification filed by Non-invasive Monitoring Systems, Inc. with the FDA for Respievents, Version 4.2.
| Device ID | K001369 |
| 510k Number | K001369 |
| Device Name: | RESPIEVENTS, VERSION 4.2 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | NON-INVASIVE MONITORING SYSTEMS, INC. 1840 WEST AVE. Miami Beach, FL 33139 |
| Contact | Marvin A Sackner, M.d. |
| Correspondent | Marvin A Sackner, M.d. NON-INVASIVE MONITORING SYSTEMS, INC. 1840 WEST AVE. Miami Beach, FL 33139 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-07-26 |