Device Classification Name |
analyzer, gas, halothane, gaseous-phase (anesthetic conc.)
|
510(k) Number |
K873194 |
Device Name |
SPECTRAMED RESPIRATORY GAS ANALYZER |
Applicant |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
PERK CROOK |
Correspondent |
DRAEGER MEDICAL, INC. |
148 B. QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
PERK CROOK |
Regulation Number | 868.1620
|
Classification Product Code |
|
Date Received | 08/13/1987 |
Decision Date | 10/30/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|