The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Renaissance Spirometry Systemwith The Optionalrenaissance Db Data Managementsoftware.
| Device ID | K944762 |
| 510k Number | K944762 |
| Device Name: | PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE |
| Classification | Spirometer, Diagnostic |
| Applicant | PURITAN BENNETT CORP. 255 BALLARDVALE ST. Wilmington, MA 01887 |
| Contact | C M Smith |
| Correspondent | C M Smith PURITAN BENNETT CORP. 255 BALLARDVALE ST. Wilmington, MA 01887 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-12-13 |