Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K010263 |
Device Name |
REMSTAR PLUS CPAP SYSTEM |
Applicant |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Applicant Contact |
DAVID J VANELLA |
Correspondent |
RESPIRONICS, INC. |
1001 MURRY RIDGE LN. |
MURRYSVILLE,
PA
15668
|
|
Correspondent Contact |
DAVID J VANELLA |
Regulation Number | 868.5905
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/29/2001 |
Decision Date | 03/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|