Non-Invasive Monitoring Systems, Inc.
FDA Regulatory Profile
Non-Invasive Monitoring Systems, Inc. appears in FDA public data with 2 recalls, 6 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1820-2012, Class II) was initiated on May 7, 2012. Its most recent 510(k) clearance was granted on August 21, 2001.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1820-2012 | Class II | USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved la | May 7, 2012 |
| Z-1819-2012 | Class II | US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved lab | May 7, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K012020 | RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC | August 21, 2001 |
| K001369 | RESPIEVENTS, VERSION 4.2 | July 26, 2000 |
| K942771 | RESPIEVENTS | February 13, 1996 |
| K942852 | RESPITRACE PT | February 13, 1996 |
| K903011 | RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL | March 29, 1991 |
| K884959 | RESPITRAK | June 8, 1989 |