The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Electronic Manometer.
| Device ID | K941308 |
| 510k Number | K941308 |
| Device Name: | NEWPORT ELECTRONIC MANOMETER |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST. UNIT A Costa Mesa, CA 92627 |
| Contact | Al Belen |
| Correspondent | Al Belen NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST. UNIT A Costa Mesa, CA 92627 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-07 |
| Decision Date | 1995-08-25 |