The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Helios Portable Liquid Oxygen System.
| Device ID | K993220 |
| 510k Number | K993220 |
| Device Name: | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | PURITAN BENNETT CORP. 3 MISSOURI RESEARCH PARK DR. St. Charles, MO 63304 -5685 |
| Contact | Tony Keaveney |
| Correspondent | Tony Keaveney PURITAN BENNETT CORP. 3 MISSOURI RESEARCH PARK DR. St. Charles, MO 63304 -5685 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 1999-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M766H850EU0 | K993220 | 000 |
| M766B70084800 | K993220 | 000 |