Pace Tech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K951226VITALMAX 4000/MINIPACK 3100/3000November 21, 1996
K953795VITALMAX 4100July 1, 1996
K944541HANDYPACK 911SCFebruary 22, 1995
K945385VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300January 31, 1995
K925701MINIPACK 911-STCAugust 11, 1994
K934385MINIPACK 3100/3000 MODIFICATIONAugust 10, 1994
K933624VITALMAX 4000July 19, 1994
K930559VITALMAX 800-CSeptember 3, 1993
K912835MINI-PACK 911 SERIESFebruary 3, 1992
K912880VITALMAX 510/520November 14, 1991
K913263VITALMAX 830 SERIESOctober 10, 1991
K905274VITALMAX 2100/2200July 17, 1991
K901066VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.August 28, 1990
K900451VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSEJuly 18, 1990
K901612VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PREApril 30, 1990
K900866OXIMAX 700April 4, 1990
K900843OXIMAX 100March 28, 1990
K880351VITAL SYSTEMMarch 22, 1988