Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K973920 |
Device Name |
STARDUST |
Applicant |
RESPIRONICS, INC. |
1501 ARDMORE BLVD. |
PITTSBURGH,
PA
15221 -4401
|
|
Applicant Contact |
RAJI S KASBEKAR |
Correspondent |
RESPIRONICS, INC. |
1501 ARDMORE BLVD. |
PITTSBURGH,
PA
15221 -4401
|
|
Correspondent Contact |
RAJI S KASBEKAR |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 10/15/1997 |
Decision Date | 05/14/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|