FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MICHELE SLEEP SCORING SYSTEMS
K Number: K112102
·
Decision Dec 20, 2011
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
155
Applicant Total
1
Review Days
151
Basic Information
- Device Name
- MICHELE SLEEP SCORING SYSTEMS
- K Number
- K112102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- YOUNES SLEEP TECHNOLOGIES
- Date Received
- July 22, 2011
- Decision Date
- December 20, 2011
- Product Code
- MNR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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