M-SERIES PRO CPAP SYTEM
FDA 510(k) clearance K052110 · decided 2005-10-20
Clearance details
- K-number
- K052110
- Device name
- M-SERIES PRO CPAP SYTEM
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-04
- Decision date
- 2005-10-20
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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