Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K813253 |
Device Name |
IC-5 VENTILATOR |
Applicant |
BIO-MED DEVICES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BIO-MED DEVICES, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 11/19/1981 |
Decision Date | 12/09/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|