Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K931542 |
Device Name |
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR |
Applicant |
NEWPORT MEDICAL INSTRUMENTS, INC. |
300 NORTH NEWPORT BLVD. |
NEWPORT BEACH,
CA
92663
|
|
Applicant Contact |
CYNDY MILLER |
Correspondent |
NEWPORT MEDICAL INSTRUMENTS, INC. |
300 NORTH NEWPORT BLVD. |
NEWPORT BEACH,
CA
92663
|
|
Correspondent Contact |
CYNDY MILLER |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 03/29/1993 |
Decision Date | 10/25/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|