510(k) K902967
- Device
- MICRO-EMED-SYSTEM
- Applicant
- NOVEL ELECTRONICS, INC.
- 510(k) number
- K902967
- Product code
- IKE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-17
- Date received
- 1990-07-06
- Regulation
- 890.1615
- Classification name
- Transducer, Miniature Pressure
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN DIEKRAGER
- Address
- 511 Eleventh Ave. S. Suite 266, Box 82 Minneapolis MN US 55415 55415
FDA Registration Numbers#
- 8010859
- 3032328006
- 3003477135
- 3039167637
- 3003857800
- 1321175
- 3003631667
- 1723702
- 2084126
- 2183733
- 3029922
- 1319182
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IKE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060125 | SONIC PALPOMETER | Palpometer Systems, Inc. | 2006-03-16 |
| K954670 | PRESSORE MONITOR | Cleveland Medical Devices, Inc. | 1995-10-30 |
| K915369 | THE EQUALIZER | Advanced Rehabilitative Technology, Inc. | 1993-03-22 |
| K915326 | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | Bar Med Pty , Ltd. | 1992-10-20 |
| K920091 | IOWA ORAL PERFORMANCE ISNTRUMENT | Breakthrough, Inc. | 1992-05-20 |
| K915897 | FPL | Wrm Computers | 1992-04-07 |
| K914780 | TALLEY SD.500 SKIN PRESSURE EVALUATOR | Talley Group, Ltd. | 1991-12-19 |
| K880912 | DYNATRON 2000 | Dynatronics Corp. | 1988-03-15 |
| K875103 | BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 | Shield Computers , Ltd. | 1988-01-20 |
| K871690 | EMED-F-SYSTEM | Novel GmbH | 1987-05-15 |
| K864499 | PODOSCOPE | Broadwest Corp. | 1987-02-04 |
| K864569 | PODODIGITAL | Broadwest Corp. | 1987-02-04 |
| K844202 | MOSS LIMB LOAD MONITOR LM101-1 | Moss Rehabilation Hospital | 1984-11-27 |
| K843634 | ASC 4080 SYSTEM | Atlantis Scientific Corp. | 1984-11-08 |
Legacy Summary#
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FDA Review#
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