MODIFICATION OF APEXPRO TELEMETRY SYSTEM
FDA 510(k) clearance K021325 · decided 2002-05-07
Clearance details
- K-number
- K021325
- Device name
- MODIFICATION OF APEXPRO TELEMETRY SYSTEM
- Applicant
- General Electric Medical Systems Information Techn
- Decision
- Substantially Equivalent
- Date received
- 2002-04-26
- Decision date
- 2002-05-07
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry Sys recall (Z-0175-2020) | GE Healthcare, LLC | 2019-10-23 |