The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Oxiscan Ii Data Management System.
| Device ID | K080348 |
| 510k Number | K080348 |
| Device Name: | OXISCAN II DATA MANAGEMENT SYSTEM |
| Classification | Oximeter |
| Applicant | AIRSEP CORP. 401 CREEKSIDE DR. Buffalo, NY 14228 -2085 |
| Contact | Peter Weiserborn |
| Correspondent | Peter Weiserborn AIRSEP CORP. 401 CREEKSIDE DR. Buffalo, NY 14228 -2085 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-10-09 |
| Summary: | summary |