Pace Tech, Inc.
Clearwater, FL, US
Pace Tech, Inc. appears in FDA device records in Clearwater, FL. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Pace Tech, Inc. between 1988 and 1996. The busiest year on record is 1990, with 5. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1990 | 5 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | DSK | Substantially Equivalent | |
| K953795 | VITALMAX 4100 | CBS | Substantially Equivalent | |
| K944541 | HANDYPACK 911SC | CCK | Substantially Equivalent | |
| K945385 | VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 | MHX | Substantially Equivalent | |
| K925701 | MINIPACK 911-STC | CCK | Substantially Equivalent | |
| K934385 | MINIPACK 3100/3000 MODIFICATION | DXN | Substantially Equivalent | |
| K933624 | VITALMAX 4000 | MHX | Substantially Equivalent | |
| K930559 | VITALMAX 800-C | CCK | Substantially Equivalent | |
| K912835 | MINI-PACK 911 SERIES | MHX | Substantially Equivalent | |
| K912880 | VITALMAX 510/520 | DQA | Substantially Equivalent | |
| K913263 | VITALMAX 830 SERIES | MHX | Substantially Equivalent | |
| K905274 | VITALMAX 2100/2200 | DRT | Substantially Equivalent | |
| K901066 | VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. | DQA | Substantially Equivalent | |
| K900451 | VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE | DRT | Substantially Equivalent | |
| K901612 | VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE | DQA | Substantially Equivalent | |
| K900866 | OXIMAX 700 | DQA | Substantially Equivalent | |
| K900843 | OXIMAX 100 | DQA | Substantially Equivalent | |
| K880351 | VITAL SYSTEM | DXN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- DSKComputer, Blood-Pressure
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain