Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K972237 |
Device Name |
HAND HELD MEDISPACER |
Applicant |
THAYER MEDICAL CORP. |
4575 SOUTH PALO VERDE RD., |
SUITE 337 |
TUCSON,
AZ
85714
|
|
Applicant Contact |
JOE LIX |
Correspondent |
THAYER MEDICAL CORP. |
4575 SOUTH PALO VERDE RD., |
SUITE 337 |
TUCSON,
AZ
85714
|
|
Correspondent Contact |
JOE LIX |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/01/1997 |
Decision Date | 07/31/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|