The following data is part of a premarket notification filed by Biomedical Monitoring Systems, Inc. with the FDA for Sleepmaster.
| Device ID | K911386 |
| 510k Number | K911386 |
| Device Name: | SLEEPMASTER |
| Classification | Monitor, Breathing Frequency |
| Applicant | BIOMEDICAL MONITORING SYSTEMS, INC. C/O RJL & ASSOCIATES 13 ENID LANE East Lyme, CT 06333 |
| Contact | Ronald Luich |
| Correspondent | Ronald Luich BIOMEDICAL MONITORING SYSTEMS, INC. C/O RJL & ASSOCIATES 13 ENID LANE East Lyme, CT 06333 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1992-04-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SLEEPMASTER 71465468 0407213 Dead/Expired |
SLEEPMASTER PRODUCTS COMPANY, INC. 1943-12-02 |
![]() SLEEPMASTER 71465467 0409026 Dead/Expired |
SLEEPMASTER PRODUCTS COMPANY, INC. 1943-12-02 |