The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan Bennett Dataflow Data Management Software.
| Device ID | K023225 |
| 510k Number | K023225 |
| Device Name: | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE |
| Classification | Spirometer, Diagnostic |
| Applicant | PURITAN BENNETT CORP. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Gina To |
| Correspondent | Gina To PURITAN BENNETT CORP. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-12-18 |
| Summary: | summary |