The following data is part of a premarket notification filed by Syva Co. with the FDA for Pfeiffer Metered Dosage System.
| Device ID | K896070 |
| 510k Number | K896070 |
| Device Name: | PFEIFFER METERED DOSAGE SYSTEM |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Rogers, Jr |
| Correspondent | Rogers, Jr SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1990-01-17 |