The following data is part of a premarket notification filed by Shanghai Intco Electrode Manufacturing Co., Ltd. with the FDA for Intco Tab Electrode.
| Device ID | K093327 |
| 510k Number | K093327 |
| Device Name: | INTCO TAB ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. 814 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | Chris Healy |
| Correspondent | Chris Healy SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. 814 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784710334 | K093327 | 000 |
| 00616784710235 | K093327 | 000 |
| 00616784710136 | K093327 | 000 |
| 00816703021347 | K093327 | 000 |
| 00816703021330 | K093327 | 000 |
| 00816703021323 | K093327 | 000 |
| 00816703021316 | K093327 | 000 |
| 00816703028667 | K093327 | 000 |
| 00816703028636 | K093327 | 000 |