LAPEX 2000
FDA 510(k) clearance K034009 · decided 2005-01-21
Clearance details
- K-number
- K034009
- Device name
- LAPEX 2000
- Applicant
- Meridian Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-24
- Decision date
- 2005-01-21
- Days to decision
- 394 days
- Clearance type
- Abbreviated
- Product code
- NHN
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.