510(k) K081035
- Device
- AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
- Applicant
- OSYPKA MEDICAL, INC.
- 510(k) number
- K081035
- Product code
- DSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-30
- Date received
- 2008-04-11
- Regulation
- 870.2770
- Classification name
- Plethysmograph, Impedance
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARKUS OSYPKA
- Address
- 7855 Ivanhoe Ave., Suite 226 La Jolla CA US 92037 92037
FDA Registration Numbers#
- 3018940143
- 9615817
- 3003971136
- 9681860
- 3032916632
- 3006113127
- 3003174284
- 3005783425
- 3014158038
- 3009077524
- 1018233
- 3018783526
- 3008642652
- 3004753774
- 3016701404
- 1316463
- 3013500228
- 3012044688
- 3011790297
- 3000126629
- 3012528160
- 3010097171
- 1320894
- 3016618143
- 9610816
- 2027046
- 3003832357
- 2221819
- 1000610255
- 9681449
- 3008716327
- 3009499478
- 3005004021
- 9610105
- 3037724692
- 3007836437
- 3009156722
- 9680010
- 3013596024
- 2025475
- 3003857828
- 3023272766
- 3020885267
- 3006082230
- 3003803088
- 3005699942
- 3042941992
- 3008483389
- 3002684743
- 3021559257
- 3007603826
- 3004782476
- 3019130
- 3011773282
- 3010849408
- 3043355869
- 3032367
- 1317188
- 3004987887
- 3004832480
- 3021242837
- 3000130829
- 1219324
- 3003695829
- 3007305624
- 2648045
- 2133641
- 2134243
- 3008240972
Source Documents#
Other 510(k) Records For Product Code DSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
| K243727 | Re:Balans | Mode Sensors AS | 2025-10-16 |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | 2025-09-09 |
| K232089 | SOZO Pro | ImpediMed Limited | 2023-10-17 |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023-06-16 |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | 2022-07-29 |
| K203473 | SOZO | ImpediMed Limited | 2021-04-19 |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020-10-02 |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020-02-21 |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | 2018-03-14 |
| K172507 | SOZO | ImpediMed Limited | 2017-12-22 |
| K172196 | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017-09-19 |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | 2015-08-06 |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | 2015-06-05 |
Legacy Summary#
summary
FDA Review#
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