MODEL 515 NEONATAL MONIOTR
FDA premarket approval P840037/S001 · decided 1986-11-19
Approval details
- PMA number
- P840037
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 515 NEONATAL MONIOTR
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Ge Medical Systems Information Technologies
- Date received
- 1986-06-19
- Decision date
- 1986-11-19
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Cardiovascular
- Expedited review
- No
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QT GUARD PLUS ANALYSIS SYSTEM (K120770) | Ge Medical Systems Information Technologies | 2012-12-06 |
| CARESCAPE MODEL V100 VITAL SIGNS MONITOR (K102426) | Ge Medical Systems Information Technologies | 2010-10-20 |
| 12SL ECG ANALYSIS PROGRAM (K092369) | Ge Medical Systems Information Technologies | 2010-02-24 |
| MARS HOLTER ANALYSIS WORKSTATION (K093141) | Ge Medical Systems Information Technologies | 2009-12-29 |
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |
| MODIFICATION TO DASH 2500 PATIENT MONITOR (K090702) | Ge Medical Systems Information Technologies | 2009-04-15 |
| CAPNOSTAT / CAPNOFLEX CO2 SYSTEM (K083750) | Ge Medical Systems Information Technologies | 2009-03-23 |
| MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE (K083639) | Ge Medical Systems Information Technologies | 2009-02-17 |