The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett 700 Renaissance Ii Spirometry System.
| Device ID | K022103 |
| 510k Number | K022103 |
| Device Name: | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM |
| Classification | Spirometer, Diagnostic |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | James Bonds |
| Correspondent | James Bonds PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-28 |
| Decision Date | 2002-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521162164 | K022103 | 000 |
| 10884521161832 | K022103 | 000 |
| 10884521151673 | K022103 | 000 |