BZM · Calculator, Pulmonary Function Interpretor (Diagnostic)
Anesthesiology · 21 CFR 868.1900 · Class 2
Overview
| Product Code | BZM |
|---|---|
| Device Name | Calculator, Pulmonary Function Interpretor (Diagnostic) |
| Regulation | 21 CFR 868.1900 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102229 | PULMOTRACK 2020 SYSTEM | Karmelsonix | Mar 4, 2011 | SESE |
| K090863 | PERSONAL WHEEZOMETER | Karmelsonix | Sep 21, 2009 | SESE |
| K071955 | WIM-PC, MODEL 1010 | Karmelsonix | Nov 1, 2007 | SESE |
| K012387 | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM | Stethographics, Inc. | Apr 23, 2002 | SESE |
| K980878 | PULMOTRACK,MODEL 1010 | Karmel Medical Acoustic Technologies , Ltd. | Dec 28, 1998 | SESE |
| K974200 | ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM | Orca Diagnostics Corp. | Jul 21, 1998 | SESE |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | Medical Graphics Corp. | Jul 1, 1996 | SESE |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | Medical Graphics Corp. | Mar 11, 1993 | SESE |
| K911143 | PB100 DIAGNOSTIC SPIROMETER | Puritan Bennett Corp. | Nov 29, 1991 | SESE |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | Medical Graphics Corp. | Jan 20, 1990 | SESE |
| K880550 | BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS | Medimicro Systems, Inc. | Jul 25, 1988 | SESE |
| K874902 | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY | Gomi Medical Instruments | Jun 7, 1988 | SESE |
| K871711 | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | Medical Graphics Corp. | Sep 25, 1987 | SESE |
| K864911 | EXERSYSTEM(TM) MMC 5000 | Med Science | Aug 21, 1987 | SESE |
| K864885 | SPIROVISION | Futuremed Div. of Future Impex Corp. | Jan 15, 1987 | SESE |
| K863953 | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | Spirometrics, Inc. | Jan 15, 1987 | SESE |
| K861929 | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 | Medical Graphics Corp. | Sep 26, 1986 | SN |
| K853190 | SUPERSPIRO | Cdx Corp. | Sep 26, 1985 | SESE |
| K851706 | UNIVERSAL COMPUTER INTERFACE SYSTEM | Vacumetrics, Inc. | May 3, 1985 | SESE |
| K842782 | PHYSIOLOGICAL ANALYZER CM-710 | Cybermedic, Inc. | Aug 17, 1984 | SESE |
Top Applicants
- Medical Graphics Corp. — 7 clearances
- Karmelsonix — 3 clearances
- Cdx Corp. — 2 clearances
- Cybermedic, Inc. — 2 clearances
- Cavitron Corp. — 1 clearance
