Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K981412 |
Device Name |
M1145 (UPS1-1.25K-1G-MP) UPS |
Applicant |
CLARY CORP. |
55 NORTHERN BLVD. |
SUITE 410 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
CLARY CORP. |
55 NORTHERN BLVD. |
SUITE 410 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/20/1998 |
Decision Date | 11/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|