Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K961318 |
Device Name |
1ST RESPONSE DISPOSABLE MANOMETER |
Applicant |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Applicant Contact |
AVIA TONEY, RAC |
Correspondent |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
AVIA TONEY, RAC |
Regulation Number | 868.2600 |
Classification Product Code |
|
Date Received | 04/05/1996 |
Decision Date | 12/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|