Device Classification Name |
set, tubing and support, ventilator (w harness)
|
510(k) Number |
K932560 |
Device Name |
VOLUME VENTILATORS |
Applicant |
LIFE SHIELD HEALTHCARE PRODUCTS, INC. |
15381 STONY CREEK WAY |
NOBLESVILLE,
IN
46060
|
|
Applicant Contact |
TIMOTHY STRUTHERS |
Correspondent |
LIFE SHIELD HEALTHCARE PRODUCTS, INC. |
15381 STONY CREEK WAY |
NOBLESVILLE,
IN
46060
|
|
Correspondent Contact |
TIMOTHY STRUTHERS |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 05/27/1993 |
Decision Date | 07/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|