Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K992192 |
Device Name |
AIRPILOTMASK, MODEL TMS-900 |
Applicant |
TIARA MEDICAL SYSTEMS, INC. |
14414 DETROIT AVE, SUITE 205 |
LAKEWOOD,
OH
44107
|
|
Applicant Contact |
GEOFFREY SLEEPER |
Correspondent |
TIARA MEDICAL SYSTEMS, INC. |
14414 DETROIT AVE, SUITE 205 |
LAKEWOOD,
OH
44107
|
|
Correspondent Contact |
GEOFFREY SLEEPER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/29/1999 |
Decision Date | 05/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|