STARDUST II
FDA 510(k) clearance K052573 · decided 2005-12-13
Clearance details
- K-number
- K052573
- Device name
- STARDUST II
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-19
- Decision date
- 2005-12-13
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- MNR
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or recall (Z-1087-2008) | Respironics, Inc. | 2008-04-24 |
| Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for recall (Z-1089-2008) | Respironics, Inc. | 2008-04-24 |