Device Classification Name |
Oximeter
|
510(k) Number |
K873078 |
Device Name |
NOVAMETRIX MODEL 505 PULSE OXIMETER |
Applicant |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
ROBERT E YOCHER |
Correspondent |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
ROBERT E YOCHER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/05/1987 |
Decision Date | 09/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|