The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Aeris 590 Oxygen Concentrator With Oci.
| Device ID | K993088 |
| 510k Number | K993088 |
| Device Name: | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI |
| Classification | Generator, Oxygen, Portable |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Tony Keaveney |
| Correspondent | Tony Keaveney PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-10-08 |
| Summary: | summary |