SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
FDA 510(k) clearance K003804 · decided 2001-08-30
Clearance details
- K-number
- K003804
- Device name
- SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
- Applicant
- Niko Medical Products
- Decision
- Substantially Equivalent
- Date received
- 2000-12-08
- Decision date
- 2001-08-30
- Days to decision
- 265 days
- Clearance type
- Abbreviated
- Product code
- DRX
- Device class
- 2
- Regulation number
- 870.2360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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| INTCO TAB ELECTRODE (K093327) | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 |
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| SKINTACT AND VARIOUS OTHER TRADENAMES (K092291) | Leonhard Lang GmbH | 2009-08-21 |
Recalls involving this device
No recalls on record reference this clearance.