The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Breeze Sleepgear With Dreamseal.
| Device ID | K002001 |
| 510k Number | K002001 |
| Device Name: | BREEZE SLEEPGEAR WITH DREAMSEAL |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | PURITAN BENNETT CORP. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Darin Busch |
| Correspondent | Darin Busch PURITAN BENNETT CORP. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-30 |
| Decision Date | 2000-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90884521134375 | K002001 | 000 |
| 10884521135628 | K002001 | 000 |
| 20884521142838 | K002001 | 000 |
| 10884521134720 | K002001 | 000 |
| 20884521141381 | K002001 | 000 |
| 20884521141398 | K002001 | 000 |
| 20884521142777 | K002001 | 000 |
| 20884521142784 | K002001 | 000 |
| 10884521135635 | K002001 | 000 |
| 20884521142852 | K002001 | 000 |
| 20884521142845 | K002001 | 000 |
| 10884521134812 | K002001 | 000 |
| 10884521135079 | K002001 | 000 |
| 10884521134713 | K002001 | 000 |