Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
FDA 510(k) clearance K003576 · decided 2001-01-25
Clearance details
- K-number
- K003576
- Device name
- Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
- Applicant
- Quinton, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-20
- Decision date
- 2001-01-25
- Days to decision
- 66 days
- Clearance type
- Abbreviated
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac S recall (Z-1757-2010) | Cardiac Science Corporation | 2010-06-04 |