Vasopulse(Tm)/Model 5000
FDA 510(k) K863803 · Sonicaid, Inc.
510(k) numberK863803
Submission
- Device name
- Vasopulse(Tm)/Model 5000
- Applicant
- Sonicaid, Inc.
Fredericksburg, VA, US - Received
- September 29, 1986
- Decision date
- May 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
Other 510(k)s with product code JOM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220527 | PADnet XpressJOM · Special | Collaborative Care Diagnostics, LLC, D.B.A.… | 10/20/2022SE |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBIJOM · Traditional | Mesi, Development of Medical Devices, Ltd.; Mesi… | 04/21/2022SE |
| K200567 | ASI Plethysmogrpah AnalyzerJOM · Traditional | Arterial Stiffness, Inc. | 02/26/2021SE |
| K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET systemJOM · Traditional | Mesi D.O.O.; Mesi, Development of Medical… | 12/11/2020SE |
| K191266 | VitalScan ANSJOM · Traditional | Medeia, Inc. | 01/15/2020SE |
| K172655 | Automated ankle brachial pressure index measuring deviceJOM · Traditional | Mesi D.O.O.; Mesi, Development of Medical… | 01/11/2018SE |
| K173696 | TBL-ABI SystemJOM · Special | Ld Technology, LLC | 12/19/2017SE |
| K143152 | TM-ABI systemJOM · Traditional | Ld Technology, LLC | 07/22/2015SE |
| K143094 | QuantaFloJOM · Traditional | Semler Scientific, Inc. | 03/05/2015SE |
| K123921 | Bodytronic 200JOM · Traditional | Bauerfeind AG | 04/26/2013SE |
More from Bauerfeind AG
| 510(k) | Device | Decision |
|---|---|---|
| K873673 | BV105 (&BV105R) Vascular Flow Detector W/OptionalDPT · Traditional | 02/26/1988SE |
| K872074 | 5 MHZ TransducerJOP · Traditional | 08/25/1987SE |
| K862720 | VASOFLO-3 & Extravascular Blood Flow ProbesDPW · Traditional | 11/17/1986SE |
| K861237 | Vasoview Duplex Imaging SystemITX · Traditional | 07/14/1986SN |
| K851102 | Vasoscreen Impedance PlethysmographDQB · Traditional | 05/16/1985SE |
| K833902 | VasoscanJOP · Traditional | 01/27/1984SE |
| K832374 | Photoflo Dual-Mode PhotoplethysmographJOM · Traditional | 12/01/1983SE |
| K833488 | SonicompHEM · Traditional | 11/28/1983SE |
| K833227 | Sonicaid Model D206E Air Emboli-DetectLBA · Traditional | 10/27/1983SE |
| K831371 | Model FM5HGM · Traditional | 06/30/1983SE |
Questions and answers
When was Vasopulse(Tm)/Model 5000 cleared by the FDA?
Vasopulse(Tm)/Model 5000 (K863803) received a 510(k) decision of Substantially Equivalent on May 6, 1987, 219 days after the submission was received.
What is the product code of K863803?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.