Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K030379 |
Device Name |
APLAB, MODEL 801D0030 |
Applicant |
SECTOR MEDICAL CORP. |
320 NORTHPOINT PKWY. |
SUITE P |
ACWORTH,
GA
30102
|
|
Applicant Contact |
BRADLEY JEFFRIES |
Correspondent |
SECTOR MEDICAL CORP. |
320 NORTHPOINT PKWY. |
SUITE P |
ACWORTH,
GA
30102
|
|
Correspondent Contact |
BRADLEY JEFFRIES |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/05/2003 |
Decision Date | 08/29/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|