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 |