The following data is part of a premarket notification filed by Non-invasive Monitoring Systems, Inc. with the FDA for Respievents Software Is Event Data Processing Sofware For A Pc.
| Device ID | K012020 |
| 510k Number | K012020 |
| Device Name: | RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | NON-INVASIVE MONITORING SYSTEMS, INC. 1840 WEST AVE. Miami Beach, FL 33139 |
| Contact | Allan F Brack |
| Correspondent | Allan F Brack 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-28 |
| Decision Date | 2001-08-21 |
| Summary: | summary |