SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
FDA 510(k) clearance K043306 · decided 2005-06-06
Clearance details
- K-number
- K043306
- Device name
- SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
- Applicant
- Skylark Device & Systems Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-01
- Decision date
- 2005-06-06
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Taipei, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.