The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Ht50 Ventilator With Humidifier Ht50-h, Newport Ht50 Ventilator Without Humidifier, Ht50-h1, Newport Ht50 Ventil.
| Device ID | K992133 |
| 510k Number | K992133 |
| Device Name: | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Contact | Robert W Dick |
| Correspondent | Robert W Dick NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N 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 | 1999-06-23 |
| Decision Date | 2000-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521208988 | K992133 | 000 |