Product code BZM
- Device name
- Calculator, Pulmonary Function Interpretor (Diagnostic)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1900
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102229 | PULMOTRACK 2020 SYSTEM | Karmelsonix | 2011-03-04 |
| K090863 | PERSONAL WHEEZOMETER | Karmelsonix | 2009-09-21 |
| K071955 | WIM-PC, MODEL 1010 | Karmelsonix | 2007-11-01 |
| K012387 | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM | Stethographics, Inc. | 2002-04-23 |
| K980878 | PULMOTRACK,MODEL 1010 | Karmel Medical Acoustic Technologies , Ltd. | 1998-12-28 |
| K974200 | ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM | Orca Diagnostics Corp. | 1998-07-21 |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | Medical Graphics Corp. | 1996-07-01 |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | Medical Graphics Corp. | 1993-03-11 |
| K911143 | PB100 DIAGNOSTIC SPIROMETER | Puritan Bennett Corp. | 1991-11-29 |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | Medical Graphics Corp. | 1990-01-20 |
| K880550 | BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS | Medimicro Systems, Inc. | 1988-07-25 |
| K874902 | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY | Gomi Medical Instruments | 1988-06-07 |
| K871711 | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | Medical Graphics Corp. | 1987-09-25 |
| K864911 | EXERSYSTEM(TM) MMC 5000 | Med Science | 1987-08-21 |
| K863953 | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | Spirometrics, Inc. | 1987-01-15 |
| K864885 | SPIROVISION | Futuremed Div. of Future Impex Corp. | 1987-01-15 |
| K861929 | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 | Medical Graphics Corp. | 1986-09-26 |
| K853190 | SUPERSPIRO | Cdx Corp. | 1985-09-26 |
| K851706 | UNIVERSAL COMPUTER INTERFACE SYSTEM | Vacumetrics, Inc. | 1985-05-03 |
| K842782 | PHYSIOLOGICAL ANALYZER CM-710 | Cybermedic, Inc. | 1984-08-17 |
| K831586 | CM-VII PHYSIOLOGIC ANALYZER | Cybermedic, Inc. | 1984-03-19 |
| K820035 | CDX 200 | Cdx Corp. | 1982-03-10 |
| K801495 | CARDIO-PULMONARY EXERCISE STRESS SYSTEM | Medical Graphics Corp. | 1980-07-21 |
| K801496 | PULMONARY LAB AUTOMATION SYSTEM | Medical Graphics Corp. | 1980-07-21 |
| K791229 | CYBER DX 100 | Cyber Diagnostics | 1979-07-30 |
| K771371 | SCREENING COMPUTEO SC-20 | Cavitron Corp. | 1977-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840178703309 | ITD | Touchpoint Medical, Inc. | 2024-07-12 |
| 00810016250357 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2019-02-22 |
| 00810016250364 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2019-02-22 |
| B3687620429040 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2018-06-18 |
| B3687620429050 | MGC Diagnostics | MEDICAL GRAPHICS CORPORATION | 2018-06-18 |