The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Rembrandt System.
| Device ID | K962865 |
| 510k Number | K962865 |
| Device Name: | REMBRANDT SYSTEM |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Ravi K Bansal |
| Correspondent | Ravi K Bansal AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-23 |
| Decision Date | 1996-10-25 |