Model Icpm & Accessories
FDA 510(k) K823681 · Electromedics, Inc.
510(k) numberK823681
Submission
- Device name
- Model Icpm & Accessories
- Applicant
- Electromedics, Inc.
Mchenry, IL, US - Received
- December 7, 1982
- Decision date
- February 23, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFC – System, Pressure Measurement, Intermittent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.1600
- Specialty
- Physical Medicine
Other 510(k)s with product code JFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924705 | Force Sensing ArrayJFC · Traditional | Force Sensing Systems | 05/12/1993SE |
| K925258 | Dynamic Pressure Monitor 2000M and 2000CJFC · Traditional | Pin Dot Products, Inc. | 03/09/1993SE |
| K925052 | Qa Pressure Measurement SystemJFC · Traditional | Gabel Medical Instruments, Ltd. | 03/09/1993SE |
| K915278 | CDG Gait Analyses SystemJFC · Traditional | Wrm Computers | 04/07/1992SE |
| K914776 | Oxford Pressure Monitor/Talley Pressure MonitorJFC · Traditional | Talley Group, Ltd. | 12/19/1991SE |
| K913510 | Mechanical Shape SensorJFC · Traditional | Pin Dot Products, Inc. | 09/23/1991SE |
| K881284 | Computerized Orthopaedic Pedotopography MachineJFC · Traditional | Nathaniel Gould Diagnostics, Inc. | 07/21/1988SE |
| K882139 | 2P-QDA Foot Pressure Systems Real TimeJFC · Traditional | Human Performance Technologies, Inc. | 06/22/1988SE |
| K861260 | PedabarographJFC · Traditional | Biokinetics, Inc. | 05/02/1986SE |
| K831800 | Texas Interface Pressure Evaluator-TipeJFC · Traditional | Tee-Kay Applied Technology | 08/16/1983SE |
More from Tee-Kay Applied Technology
| 510(k) | Device | Decision |
|---|---|---|
| K073616 | Fas-Clean Electrosurgical Coated Active BladeGEI · Traditional | 07/23/2008SE |
| K934964 | Electromedics Tympanic Temperature SensorFLL · Traditional | 03/07/1994SE |
| K933832 | Electromedics HG (Hydrogel) Series Skin Temperature SensorFLL · Traditional | 01/28/1994SE |
| K934355 | Electromedics Blood Heat ExchangerDTR · Traditional | 12/03/1993SE |
| K930154 | EL2-SERIES Blood Collection ReervoirDTN · Traditional | 07/01/1993SE |
| K926250 | Electromedics El-Series Cardiotomy ReservoirDTN · Traditional | 02/19/1993SE |
| K925412 | Electromedics Tissue Trap/ #TT280BYZ · Traditional | 02/05/1993SE |
| K915737 | Autotransfusion Blood Collection ReservoirDTN · Traditional | 09/03/1992SE |
| K910238 | Portable Auto Transfusion System 500CAC · Traditional | 06/19/1991SE |
| K910935 | Modified Pyrogen TestingDTM · Traditional | 05/16/1991SE |
Questions and answers
When was Model Icpm & Accessories cleared by the FDA?
Model Icpm & Accessories (K823681) received a 510(k) decision of Substantially Equivalent on February 23, 1983, 78 days after the submission was received.
What is the product code of K823681?
The FDA product code is JFC – System, Pressure Measurement, Intermittent, a Class I (low risk) device regulated under 21 CFR 890.1600.