HA-2 HUMAN BODY COMPOSITION ANALYZER
FDA 510(k) clearance K860749 · decided 1986-09-02
Clearance details
- K-number
- K860749
- Device name
- HA-2 HUMAN BODY COMPOSITION ANALYZER
- Applicant
- Dj Medical Instrument Corp. C/O Keller & Heckman
- Decision
- Substantially Equivalent
- Date received
- 1986-02-27
- Decision date
- 1986-09-02
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- DSB
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| BCM2-Body Composition Monitor (K250634) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
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| Zynex Monitoring System, Model CM-1600 (K223217) | Zynex Medical, Inc. | 2023-06-16 |
| Bodyport Cardiac Scale (K211585) | Bodyport, Inc. | 2022-07-29 |
| SOZO (K203473) | ImpediMed Limited | 2021-04-19 |
| SOZO Body Fluid Analyzer (K193410) | ImpediMed Limited | 2020-10-02 |
| Cardiac Monitor 1500 (K191697) | Zynex Medical, Inc. | 2020-02-21 |
| ReDS System (K180479) | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| Cardiovascular Analzyer (K172431) | Physiowave, Inc. | 2018-03-14 |
| SOZO (K172507) | ImpediMed Limited | 2017-12-22 |
Recalls involving this device
No recalls on record reference this clearance.