Device Classification Name |
monitor, oxygen, cutaneous, for infant not under gas anesthesia
|
510(k) Number |
K844079 |
Device Name |
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN |
Applicant |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
PAUL V BUDDAY |
Correspondent |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
1 BARNES INDUSTRIAL PARK RD. |
P.O. BOX 690 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
PAUL V BUDDAY |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 10/19/1984 |
Decision Date | 11/30/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|