Device Classification Name |
Calculator, Pulmonary Function Data
|
510(k) Number |
K963380 |
Device Name |
CO 2 SMO PLUS |
Applicant |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
ROBERT H SCHIFFMAN |
Correspondent |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
ROBERT H SCHIFFMAN |
Regulation Number | 868.1880
|
Classification Product Code |
|
Date Received | 08/27/1996 |
Decision Date | 01/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|