| Device Classification Name |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
|
| 510(k) Number |
K896070 |
| Device Name |
PFEIFFER METERED DOSAGE SYSTEM |
| Applicant |
| Syva Co. |
| 900 Arastradero Rd. |
| P.O. Box 10058 |
|
Palo Alto,
CA
94303
|
|
| Applicant Contact |
ROGERS, JR |
| Correspondent |
| Syva Co. |
| 900 Arastradero Rd. |
| P.O. Box 10058 |
|
Palo Alto,
CA
94303
|
|
| Correspondent Contact |
ROGERS, JR |
| Regulation Number | 868.5640 |
| Classification Product Code |
|
| Date Received | 10/19/1989 |
| Decision Date | 01/17/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|