The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Vitalert 2000 Vital Signs Monitor.
| Device ID | K882031 |
| 510k Number | K882031 |
| Device Name: | VITALERT 2000 VITAL SIGNS MONITOR |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Contact | Paul D Dougherty |
| Correspondent | Paul D Dougherty DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-16 |
| Decision Date | 1988-07-28 |