BZGClass II
Spirometer, Diagnostic
21 CFR 868.1840 / Anesthesiology
BZG is the FDA product code for Spirometer, Diagnostic, a class II device type, regulated under 21 CFR 868.1840. As of , FDA records hold 228 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- BZG
- Device name
- Spirometer, Diagnostic
- Regulation
- 21 CFR 868.1840
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 228
- Ingested recalls
- 1
Clearances, product code BZG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 2 |
| 1981 | 2 |
| 1982 | 4 |
| 1983 | 7 |
| 1984 | 15 |
| 1985 | 10 |
| 1986 | 7 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 6 |
| 1990 | 13 |
| 1991 | 10 |
| 1992 | 9 |
| 1993 | 6 |
| 1994 | 5 |
| 1995 | 8 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 7 |
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 2 |
| 2002 | 10 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 8 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 8 |
| 2010 | 4 |
| 2011 | 6 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 5 |
| 2015 | 5 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code BZG| Applicant | Clearances |
|---|---|
| Mir Medical Intl. Research SRL | 9 |
| Vitalograph Ireland Ltd. | 9 |
| Sdi Diagnostics, Inc. | 8 |
| Vitalograph, Inc. | 7 |
| Medtronic, Inc. | 6 |
| Future Impex Corp. | 5 |
| Medical Equipment Designs, Inc. | 5 |
| Morgan Scientific, Inc. | 5 |
| Sensor Medics Corp. | 5 |
| Carefusion Germany 234 GmbH | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.