The following data is part of a premarket notification filed by Vacumetrics, Inc. with the FDA for Universal Computer Interface System.
| Device ID | K851706 |
| 510k Number | K851706 |
| Device Name: | UNIVERSAL COMPUTER INTERFACE SYSTEM |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | VACUMETRICS, INC. 2261 PALMA DR. Ventura, CA 93003 |
| Contact | Ronald A Thomson |
| Correspondent | Ronald A Thomson VACUMETRICS, INC. 2261 PALMA DR. Ventura, CA 93003 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-25 |
| Decision Date | 1985-05-03 |