APEX OXIMETER
FDA 510(k) clearance K980299 · decided 1998-04-24
Clearance details
- K-number
- K980299
- Device name
- APEX OXIMETER
- Applicant
- Marquette Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-27
- Decision date
- 1998-04-24
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- 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 |
|---|---|---|
| GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 s recall (Z-0631-2010) | General Electric Medical Systems Information Technology | 2010-01-13 |