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 |