DSBClass II
Plethysmograph, Impedance
21 CFR 870.2770 / Cardiovascular
DSB is the FDA product code for Plethysmograph, Impedance, a class II device type, regulated under 21 CFR 870.2770. As of , FDA records hold 115 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- DSB
- Device name
- Plethysmograph, Impedance
- Regulation
- 21 CFR 870.2770
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 115
- Ingested recalls
- 2
Clearances, product code DSB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 1 |
| 1982 | 5 |
| 1983 | 3 |
| 1984 | 2 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 5 |
| 1988 | 9 |
| 1989 | 5 |
| 1990 | 6 |
| 1991 | 5 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 1 |
| 2007 | 2 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2025 | 3 |
| 2026 | 1 |
Applicants with the most clearances
Product code DSB| Applicant | Clearances |
|---|---|
| Cardiodynamics International Corp. | 11 |
| Bomed Medical Mfr., Ltd. | 4 |
| Impedimed, Inc. | 4 |
| Noninvasive Medical Technologies, Inc. | 4 |
| Biodynamics Corp. | 3 |
| Cardio Kinetics, Inc. | 3 |
| Cheetah Medical, Inc. | 3 |
| Electro-Diagnostic Instruments | 3 |
| Life Sciences Manufacturing, Inc. | 3 |
| Osypka Medical GmbH | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Aci Medical, LLC
- Acist Europe BV
- Acist Medical Systems, Inc.
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Analog Devices
- Baxter Healthcare - Tel Aviv
- Becton Dickinson & Co
- Becton Dickinson Canada Inc.
- BENCHMARK ELECTRONICS San Jorge
- Benchmark Electronics, Inc.
- Bodyport Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
