BZM — Calculator, Pulmonary Function Interpretor (Diagnostic) Class II
FDA product code BZM covers "Calculator, Pulmonary Function Interpretor (Diagnostic)", a Class II medical device regulated under 21 CFR 868.1900. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BZM
- Device Class
- Class II
- Regulation Number
- 868.1900
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K102229 | karmelsonix | PULMOTRACK 2020 SYSTEM | March 4, 2011 |
| K090863 | karmelsonix | PERSONAL WHEEZOMETER | September 21, 2009 |
| K071955 | karmelsonix | WIM-PC, MODEL 1010 | November 1, 2007 |
| K012387 | stethographics | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM | April 23, 2002 |
| K980878 | karmel medical acoustic technologies | PULMOTRACK,MODEL 1010 | December 28, 1998 |
| K974200 | orca diagnostics | ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM | July 21, 1998 |
| K955432 | medical graphics | CPX, CCM, CATH WITH 15% CO2 | July 1, 1996 |
| K923209 | medical graphics | MEDGRAPHICS EXERCISE CONSULT | March 11, 1993 |
| K911143 | puritan bennett | PB100 DIAGNOSTIC SPIROMETER | November 29, 1991 |
| K896345 | medical graphics | EXERCISE EVALUATION SYSTEM 2010 | January 20, 1990 |
| K880550 | medimicro systems | BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS | July 25, 1988 |
| K874902 | gomi medical instruments | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY | June 7, 1988 |
| K871711 | medical graphics | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | September 25, 1987 |
| K864911 | med science | EXERSYSTEM(TM) MMC 5000 | August 21, 1987 |
| K863953 | spirometrics | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | January 15, 1987 |
| K864885 | futuremed div. of future impex | SPIROVISION | January 15, 1987 |
| K861929 | medical graphics | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 | September 26, 1986 |
| K853190 | cdx | SUPERSPIRO | September 26, 1985 |
| K851706 | vacumetrics | UNIVERSAL COMPUTER INTERFACE SYSTEM | May 3, 1985 |
| K842782 | cybermedic | PHYSIOLOGICAL ANALYZER CM-710 | August 17, 1984 |