Device Classification Name |
Set, Tubing And Support, Ventilator (W Harness)
|
510(k) Number |
K801087 |
Device Name |
NEONATAL BREATHING CIRCUIT SYSTEM |
Applicant |
ISOTHERMAL SYSTEMS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ISOTHERMAL SYSTEMS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5975 |
Classification Product Code |
|
Date Received | 05/07/1980 |
Decision Date | 05/23/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|