Device Classification Name |
Monitor, Carbon-Dioxide, Cutaneous
|
510(k) Number |
K990960 |
Device Name |
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) |
Applicant |
PERIMED, INC. |
14900 SWEITZER LN. |
LAUREL,
MD
20707
|
|
Applicant Contact |
JAMES HOWARD |
Correspondent |
PERIMED, INC. |
14900 SWEITZER LN. |
LAUREL,
MD
20707
|
|
Correspondent Contact |
JAMES HOWARD |
Regulation Number | 868.2480
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/22/1999 |
Decision Date | 09/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|