Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K973544 |
Device Name |
VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER |
Applicant |
VACUMED, DIV. OF VACUMETRICS, INC. |
2225 EAST MURRAY HOLLADAY RD. |
SUITE 207 |
SALT LAKE CITY,
UT
84117
|
|
Applicant Contact |
JACQUILINE E FRAILEY |
Correspondent |
VACUMED, DIV. OF VACUMETRICS, INC. |
2225 EAST MURRAY HOLLADAY RD. |
SUITE 207 |
SALT LAKE CITY,
UT
84117
|
|
Correspondent Contact |
JACQUILINE E FRAILEY |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 09/18/1997 |
Decision Date | 05/26/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|