The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Compass Exhaled Tidal Volume Monitor.
| Device ID | K931542 |
| 510k Number | K931542 |
| Device Name: | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 300 NORTH NEWPORT BLVD. Newport Beach, CA 92663 |
| Contact | Cyndy Miller |
| Correspondent | Cyndy Miller NEWPORT MEDICAL INSTRUMENTS, INC. 300 NORTH NEWPORT BLVD. Newport Beach, CA 92663 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-29 |
| Decision Date | 1993-10-25 |