Device Classification Name |
Set, Tubing And Support, Ventilator (W Harness)
|
510(k) Number |
K850151 |
Device Name |
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT |
Applicant |
LIFE PRODUCTS, INC. |
2545 CENTRAL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
DOUGLAS BARNES |
Correspondent |
LIFE PRODUCTS, INC. |
2545 CENTRAL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
DOUGLAS BARNES |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 01/15/1985 |
Decision Date | 07/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|