Device Classification Name |
Mask, Oxygen
|
510(k) Number |
K781741 |
Device Name |
MASK, BI FLO NASAL OXYGEN |
Applicant |
INHAL-O-TECH MEDICAL PLASTIC |
P.O. Box 385 |
Blue Spring,
MO
64015
|
|
Applicant Contact |
J.W. Brown |
Correspondent |
INHAL-O-TECH MEDICAL PLASTIC |
P.O. Box 385 |
Blue Spring,
MO
64015
|
|
Correspondent Contact |
J.W. Brown |
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 10/07/1978 |
Decision Date | 12/01/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|