Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K862962 |
Device Name |
APNET RESPIRATION MONITOR |
Applicant |
WIRELESS MONITORS, INC. |
59 FAR POND RD. |
SOUTHAMPTON,
NY
11968
|
|
Applicant Contact |
MICHAEL SCIARRA |
Correspondent |
WIRELESS MONITORS, INC. |
59 FAR POND RD. |
SOUTHAMPTON,
NY
11968
|
|
Correspondent Contact |
MICHAEL SCIARRA |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 08/06/1986 |
Decision Date | 09/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|