Device Classification Name |
Oximeter
|
510(k) Number |
K000794 |
Device Name |
MODIFICATION TO MARSPO2, MODEL 2001 |
Applicant |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
56 CARPENTER LN. |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
ROBERT H SCHIFFMAN |
Correspondent |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
56 CARPENTER LN. |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
ROBERT H SCHIFFMAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/13/2000 |
Decision Date | 04/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|