Device Classification Name |
oximeter
|
510(k) Number |
K913516 |
Device Name |
MODEL 520A NOVAMETRIX PULSE OXIMETER |
Applicant |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
ROBERT SCHIFFMAN |
Correspondent |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
ROBERT SCHIFFMAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/07/1991 |
Decision Date | 11/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|