Dopcord PPG
FDA 510(k) K884451 · Huntleigh Technology, Inc.
510(k) numberK884451
Submission
- Device name
- Dopcord PPG
- Applicant
- Huntleigh Technology, Inc.
Manalapan, NJ, US - Received
- October 24, 1988
- Decision date
- January 12, 1989
- 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 |
|---|---|---|
| K992733 | Akron ATP9 Traction MachineITH · Traditional | 11/10/1999SE |
| K964699 | Rheo Dopplex II (RD 2)IYN · Traditional | 02/21/1997SE |
| K924516 | OP3/VP4HGL · Traditional | 06/28/1993SE |
| K910188 | Flowplus AC330 Pump GarmentsJOW · Traditional | 05/28/1991SE |
| K900882 | Multi Dopplex, MD-1JAF · Traditional | 08/22/1990SE |
| K900618 | Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional | 04/25/1990SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | 03/29/1989SE |
| K881632 | Flowtron DVT System AC500 Pump, L501 GarmentJOW · Traditional | 09/26/1988SE |
| K874688 | Flowtron AC200/2IRP · Traditional | 09/23/1988SE |
| K882644 | Huntleigh Double Bubble AIR-O-PAD-AOP5FNM · Traditional | 08/10/1988SE |
Questions and answers
When was Dopcord PPG cleared by the FDA?
Dopcord PPG (K884451) received a 510(k) decision of Substantially Equivalent on January 12, 1989, 80 days after the submission was received.
What is the product code of K884451?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.