QUICKIE RHYTHM
FDA 510(k) clearance K083249 · decided 2008-12-23
Clearance details
- K-number
- K083249
- Device name
- QUICKIE RHYTHM
- Applicant
- Sunrise Medical Hhg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-04
- Decision date
- 2008-12-23
- Days to decision
- 49 days
- Clearance type
- Special
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Longmont, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.