The following data is part of a premarket notification filed by Shanghai Intco Electrode Manufacturing Co., Ltd. with the FDA for Disposable Monitoring Electrodes.
| Device ID | K041954 |
| 510k Number | K041954 |
| Device Name: | DISPOSABLE MONITORING ELECTRODES |
| Classification | Electrode, Electrocardiograph |
| Applicant | SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | Chris Healy |
| Correspondent | Chris Healy SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-20 |
| Decision Date | 2004-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040003364 | K041954 | 000 |
| 50885380047860 | K041954 | 000 |
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| 00811382015649 | K041954 | 000 |
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| 00865773000332 | K041954 | 000 |
| 00865773000318 | K041954 | 000 |
| 00865773000301 | K041954 | 000 |
| 10849027002676 | K041954 | 000 |
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| 10849027002638 | K041954 | 000 |
| 20885380047715 | K041954 | 000 |