The following data is part of a premarket notification filed by Ineedmd with the FDA for 12-lead Glove.
| Device ID | K033559 |
| 510k Number | K033559 |
| Device Name: | 12-LEAD GLOVE |
| Classification | Electrode, Electrocardiograph |
| Applicant | INEEDMD 860 CANAL STREET Stamford, CT 06902 |
| Contact | Irving Wiesen, Esq. |
| Correspondent | Irving Wiesen, Esq. INEEDMD 860 CANAL STREET Stamford, CT 06902 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2004-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862795000418 | K033559 | 000 |
| 00862795000401 | K033559 | 000 |