XLTEK SLEEP SYSTEM
FDA 510(k) clearance K022037 · decided 2002-09-10
Clearance details
- K-number
- K022037
- Device name
- XLTEK SLEEP SYSTEM
- Applicant
- Excel Tech. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-24
- Decision date
- 2002-09-10
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oakville, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.