The following data is part of a premarket notification filed by Pace Tech, Inc. with the FDA for Vitalmax 500 Pulse Oximeter W/temp. And Respira..
| Device ID | K901066 |
| 510k Number | K901066 |
| Device Name: | VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. |
| Classification | Oximeter |
| Applicant | PACE TECH, INC. 1060 CEPHAS RD. Clearwater, FL 34625 |
| Contact | Mary J Bilgutay |
| Correspondent | Mary J Bilgutay PACE TECH, INC. 1060 CEPHAS RD. Clearwater, FL 34625 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-07 |
| Decision Date | 1990-08-28 |