The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vitalmax 800-c.
| Device ID | K930559 |
| 510k Number | K930559 |
| Device Name: | VITALMAX 800-C |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Contact | Mary J Bilgutay |
| Correspondent | Mary J Bilgutay PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-03 |
| Decision Date | 1993-09-03 |