The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Cascade I Series Humidifier Modification.
| Device ID | K936000 |
| 510k Number | K936000 |
| Device Name: | PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Ann-marie Butler |
| Correspondent | Ann-marie Butler PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-15 |
| Decision Date | 1994-08-15 |
| Summary: | summary |