Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K823936 |
Device Name |
CPAP INFANT NASAL CANNULAE SET |
Applicant |
ACKRAD LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ACKRAD LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 12/29/1982 |
Decision Date | 01/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|