Device Classification Name |
Set, Tubing And Support, Ventilator (W Harness)
|
510(k) Number |
K935582 |
Device Name |
TUBE, INHALER OXYGEN |
Applicant |
PURITAS HEALTH CARE, INC. |
219 KENT RD. |
SUITE 20 |
NEW MILFORD,
CT
06776
|
|
Applicant Contact |
THOMAS P DIMAIO |
Correspondent |
PURITAS HEALTH CARE, INC. |
219 KENT RD. |
SUITE 20 |
NEW MILFORD,
CT
06776
|
|
Correspondent Contact |
THOMAS P DIMAIO |
Regulation Number | 868.5975
|
Classification Product Code |
|
Date Received | 11/18/1993 |
Decision Date | 01/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|