Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K052335 |
Device Name |
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA |
Applicant |
ACCUTRON, INC. |
13605 WEST 7TH AVENUE |
GOLDEN,
CO
80401 -4604
|
|
Applicant Contact |
ROBERT N CLARK |
Correspondent |
ACCUTRON, INC. |
13605 WEST 7TH AVENUE |
GOLDEN,
CO
80401 -4604
|
|
Correspondent Contact |
ROBERT N CLARK |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 08/26/2005 |
Decision Date | 11/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|