The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion Liquid Oxygen System.
| Device ID | K861503 |
| 510k Number | K861503 |
| Device Name: | COMPANION LIQUID OXYGEN SYSTEM |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Hartley C Ericson |
| Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-23 |
| Decision Date | 1986-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M766B775532000 | K861503 | 000 |
| M766B775099000 | K861503 | 000 |