Z1 CPAP SYSTEM
FDA 510(k) clearance K140929 · decided 2014-10-17
Clearance details
- K-number
- K140929
- Device name
- Z1 CPAP SYSTEM
- Applicant
- Human Design Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-04-09
- Decision date
- 2014-10-17
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
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| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
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Recalls involving this device
No recalls on record reference this clearance.