Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K180510 |
Device Name |
NS 120P-TRS Airway Pressure Gauge |
Applicant |
Instrumentation Industries, Inc. |
2990 Industrial Blvd. |
Bethel Park,
PA
15102
|
|
Applicant Contact |
Doris Walter |
Correspondent |
Instrumentation Industries, Inc. |
2990 Industrial Blvd. |
Bethel Park,
PA
15102
|
|
Correspondent Contact |
Doris Walter |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 02/27/2018 |
Decision Date | 05/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|