ARIATELE TELEMETRY TRANSMITTER (96281)— 510(k) K121480
Substantially EquivalentSpacelabs Healthcare
FDA 510(k) clearance K121480 for ARIATELE TELEMETRY TRANSMITTER (96281), Substantially Equivalent on 2012-06-06. Applicant: Spacelabs Healthcare. Device class: 2.
Clearance details
- Applicant
- Spacelabs Healthcare
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Nederland, CO, US
Recent devices under product code MHX
view allMore clearances from Spacelabs Healthcare
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K121480
K-number listed on FDA's recall record- Z-2586-2014 — ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
- Z-0871-2014 — ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121480.
Data sourced from openFDA. This site is unofficial and independent of the FDA.