Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K002465 |
Device Name |
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 |
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 |
|
Date Received | 08/11/2000 |
Decision Date | 09/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|