The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vitalmax 4100.
| Device ID | K953795 |
| 510k Number | K953795 |
| Device Name: | VITALMAX 4100 |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Contact | Ilhan M Bilgutay |
| Correspondent | Ilhan M Bilgutay PACE TECH, INC. 510 GARDEN AVE. NORTH Clearwater, FL 33755 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-14 |
| Decision Date | 1996-07-01 |