510(k) K874300
- Device
- AESTHESIOMETER
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K874300
- Product code
- GWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-06
- Date received
- 1987-10-20
- Regulation
- 882.1200
- Classification name
- Discriminator, Two-point
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERTY R MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
FDA Registration Numbers#
- 3014334038
- 3010595915
- 3009746042
- 8040255
- 2432177
- 8010665
- 3004905643
- 3003418325
- 1836161
- 3001084743
- 8030607
- 9610612
- 3011497622
- 2939821
- 8040278
- 3005809810
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944234 | TCD OR TCD NEUROPATHY STAR | Jcm Management & Planning Co. | 1995-03-08 |
Legacy Summary#
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FDA Review#
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