510(k) K925258
- Device
- DYNAMIC PRESSURE MONITOR 2000M AND 2000C
- Applicant
- PIN DOT PRODUCTS, INC.
- 510(k) number
- K925258
- Product code
- JFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-03-09
- Date received
- 1992-10-19
- Regulation
- 890.1600
- Classification name
- System, Pressure Measurement, Intermittent
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL SILVERMAN
- Address
- 6001 Gross Pt. Rd. Niles IL US 60648 60648
FDA Registration Numbers#
- 3038284233
- 2029188
- 3031700059
- 3007703436
- 3013783488
- 3008487639
- 9616086
- 3014174644
- 3006543248
- 3019096928
- 3003771601
- 3009936767
- 3031887985
- 9681553
- 3029904430
- 1527846
- 2921578
- 3003995459
- 3006644670
- 2438690
- 3009973586
- 3027728081
- 3008955775
- 1650347
- 3006636961
- 3019838024
- 3042969693
- 3008630266
- 3015338588
- 3013426279
- 1221639
- 3025338249
- 3012901801
- 3017264244
- 3016096099
- 3013846071
- 3015282442
- 3029956967
- 3006462771
- 3007307487
Source Documents#
Other 510(k) Records For Product Code JFC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924705 | FORCE SENSING ARRAY | Force Sensing Systems | 1993-05-12 |
| K925052 | QA PRESSURE MEASUREMENT SYSTEM | Gabel Medical Instruments, Ltd. | 1993-03-09 |
| K915278 | CDG GAIT ANALYSES SYSTEM | Wrm Computers | 1992-04-07 |
| K914776 | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | Talley Group, Ltd. | 1991-12-19 |
| K913510 | MECHANICAL SHAPE SENSOR | Pin Dot Products, Inc. | 1991-09-23 |
| K881284 | COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE | Nathaniel Gould Diagnostics, Inc. | 1988-07-21 |
| K882139 | 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME | Human Performance Technologies, Inc. | 1988-06-22 |
| K861260 | PEDABAROGRAPH | Biokinetics, Inc. | 1986-05-02 |
| K831800 | TEXAS INTERFACE PRESSURE EVALUATOR-TIPE | Tee-Kay Applied Technology | 1983-08-16 |
| K823681 | MODEL ICPM & ACCESSORIES | Electromedics, Inc. | 1983-02-23 |
Legacy Summary#
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FDA Review#
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