Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K861743 |
Device Name |
AS165 RESPIRATION MONITOR |
Applicant |
AIR-SHIELDS, INC. |
330 JACKSONVILLE RD. |
HATBORO,
PA
19040
|
|
Applicant Contact |
FRANCIS X CASEY |
Correspondent |
AIR-SHIELDS, INC. |
330 JACKSONVILLE RD. |
HATBORO,
PA
19040
|
|
Correspondent Contact |
FRANCIS X CASEY |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/06/1986 |
Decision Date | 05/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|