The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion Mini Oxygen Saver.
Device ID | K873901 |
510k Number | K873901 |
Device Name: | COMPANION MINI OXYGEN SAVER |
Classification | Conserver, Oxygen |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Steven J Ojala |
Correspondent | Steven J Ojala PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-24 |
Decision Date | 1987-12-02 |