Exercise Evaluation System 2010
FDA 510(k) K896345 · Medical Graphics Corp.
510(k) numberK896345
Submission
- Device name
- Exercise Evaluation System 2010
- Applicant
- Medical Graphics Corp.
St. Paul, MN, US - Received
- November 3, 1989
- Decision date
- January 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZM – Calculator, Pulmonary Function Interpretor (Diagnostic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1900
- Specialty
- Anesthesiology
Other 510(k)s with product code BZM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102229 | Pulmotrack 2020 SystemBZM · Special | Karmelsonix | 03/04/2011SE |
| K090863 | Personal WheezometerBZM · Traditional | Karmelsonix | 09/21/2009SE |
| K071955 | Wim-Pc, Model 1010BZM · Special | Karmelsonix | 11/01/2007SE |
| K012387 | STG Multichannel Lung Sound Analysis SystemBZM · Traditional | Stethographics, Inc. | 04/23/2002SE |
| K980878 | Pulmotrack,Model 1010BZM · Traditional | Karmel Medical Acoustic Technologies , Ltd. | 12/28/1998SE |
| K974200 | Orca Cardiopulmonary Exercise Testing SystemBZM · Traditional | Orca Diagnostics Corp. | 07/21/1998SE |
| K955432 | CPX, CCM, Cath with 15% CO2BZM · Traditional | Medical Graphics Corp. | 07/01/1996SE |
| K923209 | Medgraphics Exercise ConsultBZM · Traditional | Medical Graphics Corp. | 03/11/1993SE |
| K911143 | PB100 Diagnostic SpirometerBZM · Traditional | Puritan Bennett Corp. | 11/29/1991SE |
| K880550 | Burrows-Knudson Automated Lung Function Inter. SysBZM · Traditional | Medimicro Systems, Inc. | 07/25/1988SE |
More from Medimicro Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 10/17/2024SE |
| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 04/12/2019SE |
| K152585 | Resmon PRO FULLPNV · Traditional | 06/24/2016SE |
| K070858 | Express SeriesBZL · Special | 04/16/2007SE |
| K061731 | Medgraphics Ultima SystemBZL · Special | 09/06/2006SE |
| K955432 | CPX, CCM, Cath with 15% CO2BZM · Traditional | 07/01/1996SE |
| K943259 | 1085 Ultimate E PlethysmographCCM · Traditional | 04/10/1995SE |
| K923209 | Medgraphics Exercise ConsultBZM · Traditional | 03/11/1993SE |
| K912906 | Medgraphics Pf/DxBZL · Traditional | 02/04/1992SE |
| K896396 | Mida System, Models 1000/1100DYC · Traditional | 01/18/1990SE |
Questions and answers
When was Exercise Evaluation System 2010 cleared by the FDA?
Exercise Evaluation System 2010 (K896345) received a 510(k) decision of Substantially Equivalent on January 20, 1990, 78 days after the submission was received.
What is the product code of K896345?
The FDA product code is BZM – Calculator, Pulmonary Function Interpretor (Diagnostic), a Class II (moderate risk) device regulated under 21 CFR 868.1900.