BIOFLEX LD-R100 TREATMENT HEAD
FDA 510(k) clearance K081355 · decided 2008-12-18
Clearance details
- K-number
- K081355
- Device name
- BIOFLEX LD-R100 TREATMENT HEAD
- Applicant
- Meditech International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-14
- Decision date
- 2008-12-18
- Days to decision
- 218 days
- Clearance type
- Abbreviated
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Toronto, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.