Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K992133 |
Device Name |
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL |
Applicant |
NEWPORT MEDICAL INSTRUMENTS, INC. |
760 WEST 16TH ST., BLDG. N |
COSTA MESA,
CA
92627
|
|
Applicant Contact |
ROBERT W DICK |
Correspondent |
NEWPORT MEDICAL INSTRUMENTS, INC. |
760 WEST 16TH ST., BLDG. N |
COSTA MESA,
CA
92627
|
|
Correspondent Contact |
ROBERT W DICK |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/23/1999 |
Decision Date | 08/04/2000 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|