The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Vasopulse(tm)/model 5000.
| Device ID | K863803 |
| 510k Number | K863803 |
| Device Name: | VASOPULSE(TM)/MODEL 5000 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
| Contact | Robert D Waxham |
| Correspondent | Robert D Waxham SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-29 |
| Decision Date | 1987-05-06 |