The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Communicat Protocol Interface Adaptor.
| Device ID | K940739 |
| 510k Number | K940739 |
| Device Name: | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Contact | Al Belen |
| Correspondent | Al Belen NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-17 |
| Decision Date | 1995-03-07 |