Device Classification Name |
monitor, airway pressure (includes gauge and/or alarm)
|
510(k) Number |
K973347 |
Device Name |
TSX PRM PULMONARY RESUSCITATION MONITOR |
Applicant |
SPIRACLE TECHNOLOGY |
16520 HARBOR BLVD., UNIT D |
FOUNTAIN VALLEY,
CA
92708
|
|
Applicant Contact |
GUY GANSEL |
Correspondent |
SPIRACLE TECHNOLOGY |
16520 HARBOR BLVD., UNIT D |
FOUNTAIN VALLEY,
CA
92708
|
|
Correspondent Contact |
GUY GANSEL |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 09/05/1997 |
Decision Date | 07/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|