The following data is part of a premarket notification filed by Vascucare, Inc. with the FDA for Respiratory Airway Tube Monitor (ratm).
| Device ID | K883158 |
| 510k Number | K883158 |
| Device Name: | RESPIRATORY AIRWAY TUBE MONITOR (RATM) |
| Classification | Monitor, Breathing Frequency |
| Applicant | VASCUCARE, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Contact | Suzanne Letso |
| Correspondent | Suzanne Letso VASCUCARE, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1989-03-06 |