Dynamic Pressure Monitor 2000M and 2000C
FDA 510(k) K925258 · Pin Dot Products, Inc.
510(k) numberK925258
Submission
- Device name
- Dynamic Pressure Monitor 2000M and 2000C
- Applicant
- Pin Dot Products, Inc.
Niles, IL, US - Received
- October 19, 1992
- Decision date
- March 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K823681 | Model Icpm & AccessoriesJFC · Traditional | Electromedics, Inc. | 02/23/1983SE |
More from Electromedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913510 | Mechanical Shape SensorJFC · Traditional | 09/23/1991SE |
| K913553 | Pin Dot Growth/Dial LinksKNN · Traditional | 09/05/1991SE |
| K913550 | Pin Dot Trunion MountsKNN · Traditional | 09/05/1991SE |
| K913549 | Pin Dot Mounting BracketsKNN · Traditional | 09/05/1991SE |
| K913548 | Pin Dot Aluminum PanKNN · Traditional | 09/05/1991SE |
| K913546 | Impala CastersKNN · Traditional | 09/05/1991SE |
| K913545 | Pin Dot Flip-Down AbductorKNN · Traditional | 09/05/1991SE |
| K913511 | Impala AxlesKNN · Traditional | 09/05/1991SE |
| K913509 | Impala WheelsKNN · Traditional | 09/05/1991SE |
| K913507 | ArmrestKNN · Traditional | 09/05/1991SE |
Questions and answers
When was Dynamic Pressure Monitor 2000M and 2000C cleared by the FDA?
Dynamic Pressure Monitor 2000M and 2000C (K925258) received a 510(k) decision of Substantially Equivalent on March 9, 1993, 141 days after the submission was received.
What is the product code of K925258?
The FDA product code is JFC – System, Pressure Measurement, Intermittent, a Class I (low risk) device regulated under 21 CFR 890.1600.