510(k) K984409
- Device
- ELK LASER FILM DIGITIZER
- Applicant
- NISHIMOTO SANGYO CO., LTD.
- 510(k) number
- K984409
- Product code
- LMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-12
- Date received
- 1998-12-09
- Regulation
- 892.2030
- Classification name
- Digitizer, Image, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- GARY J ALLSEBROOK
- Address
- 16303 Panoramic Way San Leandro CA US 94578 94578
FDA Registration Numbers
- 3010461419
- 3026970882
- 3039346136
- 3007766685
- 3015976667
- 3009717300
- 1316463
- 3008596921
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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