VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
FDA 510(k) clearance K042401 · decided 2004-10-07
Clearance details
- K-number
- K042401
- Device name
- VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
- Applicant
- American Track Roadsters, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-03
- Decision date
- 2004-10-07
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.