TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
FDA 510(k) clearance K831800 · decided 1983-08-16
Clearance details
- K-number
- K831800
- Device name
- TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
- Applicant
- Tee-Kay Applied Technology
- Decision
- Substantially Equivalent
- Date received
- 1983-05-23
- Decision date
- 1983-08-16
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- JFC
- Device class
- 1
- Regulation number
- 890.1600
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FORCE SENSING ARRAY (K924705) | Force Sensing Systems | 1993-05-12 |
| DYNAMIC PRESSURE MONITOR 2000M AND 2000C (K925258) | Pin Dot Products, Inc. | 1993-03-09 |
| QA PRESSURE MEASUREMENT SYSTEM (K925052) | Gabel Medical Instruments, Ltd. | 1993-03-09 |
| CDG GAIT ANALYSES SYSTEM (K915278) | Wrm Computers | 1992-04-07 |
| OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (K914776) | Talley Group, Ltd. | 1991-12-19 |
| MECHANICAL SHAPE SENSOR (K913510) | Pin Dot Products, Inc. | 1991-09-23 |
| COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE (K881284) | Nathaniel Gould Diagnostics, Inc. | 1988-07-21 |
| 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME (K882139) | Human Performance Technologies, Inc. | 1988-06-22 |
| PEDABAROGRAPH (K861260) | Biokinetics, Inc. | 1986-05-02 |
| MODEL ICPM & ACCESSORIES (K823681) | Electromedics, Inc. | 1983-02-23 |
Recalls involving this device
No recalls on record reference this clearance.