ARIATELE TELEMETRY TRANSMITTER (96281)
FDA 510(k) clearance K121480 · decided 2012-06-06
Clearance details
- K-number
- K121480
- Device name
- ARIATELE TELEMETRY TRANSMITTER (96281)
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2012-05-18
- Decision date
- 2012-06-06
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient mon recall (Z-2586-2014) | Spacelabs Healthcare Inc | 2014-09-04 |
| ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended f recall (Z-0871-2014) | Spacelabs Healthcare, Llc | 2014-01-30 |