Medical Graphics Corp.
Saint Paul, MN, US
MEDICAL GRAPHICS CORP. appears in FDA device records in Saint Paul, MN. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Medical Graphics Corp. between 1980 and 2024. The busiest year on record is 1980, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 3 |
| 1981 | 1 |
| 1982 | 3 |
| 1984 | 1 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1990 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic Software | BTY | Substantially Equivalent | |
| K181912 | Ascent Cardiorespiratory Diagnostic Software | BTY | Substantially Equivalent | |
| K152585 | Resmon PRO FULL | PNV | Substantially Equivalent | |
| K070858 | EXPRESS SERIES | BZL | Substantially Equivalent | |
| K061731 | MEDGRAPHICS ULTIMA SYSTEM | BZL | Substantially Equivalent | |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | BZM | Substantially Equivalent | |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | CCM | Substantially Equivalent | |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | BZM | Substantially Equivalent | |
| K912906 | MEDGRAPHICS PF/DX | BZL | Substantially Equivalent | |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | BZM | Substantially Equivalent | |
| K896396 | MIDA SYSTEM, MODELS 1000/1100 | DYC | Substantially Equivalent | |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | KRI | Substantially Equivalent | |
| K871711 | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | BZM | Substantially Equivalent | |
| K861929 | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 | BZM | Substantially Equivalent for Some Indications | |
| K861486 | SPIROMETRY MODULE | BTY | Substantially Equivalent | |
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | BXW | Substantially Equivalent | |
| K852088 | SYSTEM 1085 BODY PLETHYSMOGRAPH | CCM | Substantially Equivalent | |
| K833756 | SYSTEM 5000 | DXG | Substantially Equivalent | |
| K822986 | PULMONARY FUNCTION LAB SYSTEM 1070 | BZC | Substantially Equivalent | |
| K820475 | MGC/LITTON 2300 | BZL | Substantially Equivalent | |
| K820476 | KEM-2 | BXB | Substantially Equivalent | |
| K812792 | PFT SCREENER (SYSTEM 1100) | BTY | Substantially Equivalent | |
| K801497 | INFANT VENTILATORY MEASUREMENT SYSTEM | BZC | Substantially Equivalent | |
| K801496 | PULMONARY LAB AUTOMATION SYSTEM | BZM | Substantially Equivalent | |
| K801495 | CARDIO-PULMONARY EXERCISE STRESS SYSTEM | BZM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183022 | 2183022 | MEDICAL GRAPHICS CORP. | 350 Oak Grove Pkwy, Saint Paul, MN 55127 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- BTYCalculator, Predicted Values, Pulmonary Function
- BZCCalculator, Pulmonary Function Data
- BZMCalculator, Pulmonary Function Interpretor (Diagnostic)
- BXWCalibrator, Volume, Gas
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- BZLComputer, Oxygen-Uptake
- BXBExerciser, Powered
- PNVImpedance Measuring Device Utilizing Oscillation Techniques
- CCMPlethysmograph, Pressure
- JAXPneumotachometer
- MXASystem, Test, Breath Nitric Oxide
- IOLTreadmill, Powered
- DYCVectorcardiograph
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