STAIRMASTER MODEL 6000 ERGOMETER
FDA 510(k) clearance K912140 · decided 1991-12-17
Clearance details
- K-number
- K912140
- Device name
- STAIRMASTER MODEL 6000 ERGOMETER
- Applicant
- Tri-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-14
- Decision date
- 1991-12-17
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- ISD
- Device class
- 2
- Regulation number
- 890.5360
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fort Woth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.