The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion 800 Portable Nebulizer Compressor (c800).
| Device ID | K921809 |
| 510k Number | K921809 |
| Device Name: | COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Marshall Smith |
| Correspondent | Marshall Smith PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-15 |
| Decision Date | 1992-12-04 |