Device Classification Name |
Pneumotachometer
|
510(k) Number |
K853085 |
Device Name |
PAX METER |
Applicant |
PEACE MEDICAL, INC. |
9 GREAT MEADOW LN. |
EAST HANOVER,
NJ
07936
|
|
Applicant Contact |
KEVIN FEGAN |
Correspondent |
PEACE MEDICAL, INC. |
9 GREAT MEADOW LN. |
EAST HANOVER,
NJ
07936
|
|
Correspondent Contact |
KEVIN FEGAN |
Regulation Number | 868.2550
|
Classification Product Code |
|
Date Received | 07/23/1985 |
Decision Date | 09/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|