The following data is part of a premarket notification filed by Pace Tech Medical Monitors, Inc. with the FDA for Vitalmax 530.
Device ID | K932203 |
510k Number | K932203 |
Device Name: | VITALMAX 530 |
Classification | Oximeter |
Applicant | PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH Clearwater, FL 34615 -4126 |
Contact | Mary Bilgutay |
Correspondent | Mary Bilgutay PACE TECH MEDICAL MONITORS, INC. 510 GARDEN AVE. NORTH Clearwater, FL 34615 -4126 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-06 |
Decision Date | 1994-07-19 |