IKE — Transducer, Miniature Pressure Class I
FDA product code IKE covers "Transducer, Miniature Pressure", a Class I medical device regulated under 21 CFR 890.1615. Submissions are reviewed by the Physical Medicine panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IKE
- Device Class
- Class I
- Regulation Number
- 890.1615
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060125 | palpometer systems | SONIC PALPOMETER | March 16, 2006 |
| K954670 | cleveland medical devices | PRESSORE MONITOR | October 30, 1995 |
| K915369 | advanced rehabilitative technology | THE EQUALIZER | March 22, 1993 |
| K915326 | bar med pty | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | October 20, 1992 |
| K920091 | breakthrough | IOWA ORAL PERFORMANCE ISNTRUMENT | May 20, 1992 |
| K915897 | wrm computers | FPL | April 7, 1992 |
| K914780 | talley group | TALLEY SD.500 SKIN PRESSURE EVALUATOR | December 19, 1991 |
| K902967 | novel electronics | MICRO-EMED-SYSTEM | September 17, 1990 |
| K880912 | dynatronics | DYNATRON 2000 | March 15, 1988 |
| K875103 | shield computers | BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 | January 20, 1988 |
| K871690 | novel | EMED-F-SYSTEM | May 15, 1987 |
| K864499 | broadwest | PODOSCOPE | February 4, 1987 |
| K864569 | broadwest | PODODIGITAL | February 4, 1987 |
| K844202 | moss rehabilation hospital | MOSS LIMB LOAD MONITOR LM101-1 | November 27, 1984 |
| K843634 | atlantis scientific | ASC 4080 SYSTEM | November 8, 1984 |