ELK LASER IMAGER, MODEL EL-DRY 4000— 510(k) K011949
Substantially EquivalentNishimoto Sangyo Co., Ltd.
FDA 510(k) clearance K011949 for ELK LASER IMAGER, MODEL EL-DRY 4000, Substantially Equivalent on 2001-08-29. Applicant: Nishimoto Sangyo Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nishimoto Sangyo Co., Ltd.
- Product code
- Code LMC
- Device class
- Class 2
- Regulation
- 21 CFR 892.2040
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Leandro, CA, US
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